Spineart Perla receives FDA 510(k) marketing clearance
The Perla system is intended for stabilisation of spinal segments as an adjunct to fusion of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3).
FDA clears Stryker Tritanium PL posterior lumbar cage
The posterior lumbar cage is intended for use in patients with degenerative disc disease, grade I spondylolisthesis and degenerative scoliosis.
Cardinal Spine cervical vertebral body replacement device receives FDA 510(k) clearance
PaxMed International has announced that it has been granted US Food and Drug Administration 510(k) clearance to market the Cardinal Spine C-VBR (cervical vertebral body replacement).
Tyber Medical receives FDA clearance for BioTy modified surface treatment
Tyber Medical has received US Food and Drug Administration clearance for BioTy, a modified surface treatment for use on their headless cannulated trauma screw system.
ulrich medical USA launches uNion cervical plate system
The uNion cervical plate system is a titanium alloy spinal implant device used to provide mechanical stabilisation and anterior fixation of the cervical spine as an adjunct to fusion.
Invivo Therapeutics adds University of Louiseville Hospital to INSPIRE study
The University of Louisville is also the Data Management Center for the Christopher and Dana Reeve Foundation's North American Clinical Trials Network for the Treatment of Spinal Cord Injury; the largest research network for spinal cord injury in the USA.
California workers’ spinal surgery compensation declines
A California Workers' Compensation Institute study has found a 21% reduction in the number of workers’ compensation implant-eligible spinal surgeries between 2012 and 2014.
EOS imaging and Stryker announce co-promotion agreement for the UK
Under the exclusive agreement, Stryker's sales team in the UK will promote EOS imaging's products to its existing and prospective customers.
Bioventus introduces new spinal surgery products at AAOS 2016
Bioventus has introduced several new products at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons.
PEEK-coated implants generate particulate debris upon impaction
Data from a Titan Spine biomechanical study demonstrating that titanium coated polyetheretherketone implants generate particulate debris during impactionhave been published in The Spine Journal.
InVivo Therapeutic names Vidant Medical Center as new INSPIRE study site
Vidant Medical Center is the only level one trauma centre in eastern North Carolina and is the primary teaching hospital for the East Carolina University's Brody School of Medicine.
Mindfulness meditation can lead to back pain relief in older adults
Mindfulness meditation programs can help reduce severe pain and increase function for older adults with chronic low back pain, according to new research.
ADHD medications associated with low bone density of the lumbar spine...
Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) have shown decreased bone density of the lumbar spine in a recent study.
Average at-home recovery for AIS spinal fusion estimated at 42 days
New research has estimated that the median number of at-home recovery days following spinal fusion for adolescent idiopathic scoliosis is 42.
Half of Americans have a musculoskeletal condition leading to US$213 billion...
A report issued by the United States Bone and Joint Initiative (USBJI) estimates that 126.6 million Americans "half of the adult population "are affected by a musculoskeletal condition.
US FDA accepts modular submission and review process for InVivo Therapeutics’...
The US Food and Drug Administration has accepted InVivo Therapeutics' proposed humanitarian device exemption modular shell submission and review process for its Neuro-spinal scaffold.
Osteopathic manipulative treatment improves low back pain
Two studies have found that osteopathic manipulative treatment reduced pain and improved function in patients suffering from chronic, nonspecific low back pain.
Safe Orthopaedics appoints Pierre Dumouchel as interim chief executive officer
Dumouchel will initiate a refocus of the company's activities on France, Europe, and emerging markets, where it has perceived strong demand for its products.
Stryker launch Xia 4.5 cortical trajectory implants and instruments for LITe...
The Xia cortical trajectory implants and instruments are designed for use in less invasive LITe LIF posterior lumbar interbody fusion procedures.
Amedica and Celling Biosciences to collaborate on biologically enhanced spinal fusion...
Celling Biosciences have produced research indicating mesenchymal stem cells can be optimised and proliferate when using silicon nitride, compared to the current PEEK and titanium biomaterial standards.
EOS imaging granted CE mark for spineEOS online 3D surgical planning...
This marks the third EOSapp software planning option offered by the company, following its hipEOS and kneeEOS products.
US patent granted for Signus Rotaio artificial cervical disc
The patent relates to the anatomical prosthesis design, which is capable of resisting the high forces exerted while the patient is moving.
InVivo Therapeutics announces new objective performance criteria for INSPIRE
One quarter of patients must improve by at least one AIS grade by six months post-implantation in the study of InVivo's Neuro-Spinal Scaffold.
Precision Spine expands space and jobs at Mississippi, USA manufacturing facility
Precision Spine has added a third building to its Pearl, Mississippi campus, expanding the total manufacturing facility footprint by 30% to just under 30,000 square feet of space and creating 25 new jobs.
Stryker launches first cervical interbody fusion device featuring Aero technology
Stryker's Spine division has introduced the Aero-C cervical stability system at the 2016 American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Florida, USA.
Curtis Selquist elected chairman of RTI Surgical’s board
Curtis M Selquist is to succeed Dean Bergy as chairman of the board for RTI Surgical, effective immediately. Peter F Gearen has also been named vice chairman of the board of directors.
Five-year data demonstrate long-term therapeutic effect of Paradigm Spine’s coflex compared...
The results of this study with 5-year follow-up support that decompression and interlaminar stabilisation is an effective and sustainable treatment option, according to the authors.
Spinal procedures completed successfully with new Vital 5 ReLeaf catheter
A series of orthopaedic and spinal procedures have been completed using the Vital 5 ReLeaf catheter in Logan, and Chicago, USA.
FDA confirms Robert Califf as new commissioner
The US Food and Drug Administration (FDA) has confirmed the appointment of Robert Califf as its 22nd commissioner, following a US Senate vote of 88 to 4 in his favour. This appointment follows his role as Deputy Commissioner of the FDA Office of Medical Products and Tobacco, a position he has held since January 2015.
Hebrew University students develop fibre optic guidewire for spinal fusion surgery
Students from Hebrew University's BioDesign innovation programme develop an opto-electronic drilling system designed to facilitate highly accurate spinal fusion surgery with minimal side effects.
Bone Therapeutics’ Allob data show spinal fusion and absence of intervertebral...
Pre-clinical and positive early clinical efficacy data of the Allob Phase IIA spinal fusion trial show spinal fusion on computed tomography scans and absence of intervertebral motion on dynamic x-rays.
Students at The Hebrew University develop fibre optic guidewire with minimal...
The team developed BendGuide, an opto-electronic drilling system that monitors and detects minute changes in guide-wire trajectory during surgery.
Pulsed electromagnetic field therapy may reduce cellular inflammation associated with disc...
A study has shown that pulsed electromagnetic field therapy may reduce cellular inflammation and degradation associated with disc degeneration in human intervertebral disc cells.
RTI Surgical launches Unison-C anterior cervical fixation system
This anterior cervical fixation system is indicated for stand-alone interbody fusion for the treatment of single-level degenerative disc disease from C2 to T1, in skeletally mature patients.
InVivo Therapeutics INSPIRE study enrols sixth patient
InVivo Therapeutics has enrolled a sixth patient into its INSPIRE study at the Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, USA.
Researchers discover new therapeutic target for spinal muscular atrophy
Neuroscientists have discovered a specific enzyme that plays a critical role in spinal muscular atrophy. Suppressing this enzyme's activity could markedly reduce the disease's severity.
Amedica to present 24-month CASCADE clinical trial results
The blinded, randomised clinical trial compared spinal fusion between its composite silicon nitrade fusion devices with a central, cancellous core, to PEEK spaces filled with bone autograft.
Intradiscal biacuplasty sustains long-term superiority over conservative treatment for discogenic low-back...
A new study has found that patients treated with intradiscal biacuplasty for discogenic back pain maintained benefits a year later, as did those who transferred to IDB treatment mid-study.
Ten more US states receive positive local coverage decisions for MIS...
This will leave First Coast Service Options of Florida the only Medicare Administrative Contractor yet to provide coverage for minimally invasive sacroiliac joint fusion surgery.
Elevated rate of lumbar disc herniation in astronauts post-spaceflight likely caused...
Research has concluded that the increased rate of intervertebral lumbar disc (IVD) herniation is most likely caused by an increase in lumbar disc hydration due to the reduced spinal loads experienced in space.
SpineGuard granted national vendor contract by Hospital Corporation of America
This network includes more than 167 hospitals and 112 standalone surgery centres in the USA, held under the HealthTrust purchasing group.
Twelve patients treated without safety concerns in Bone Therapeutics Allob trial
Bone Therapeutics is attempting to address the lack of fusion which can occur with the treatment of degenerative disc disease by spinal fusion with Allob, its allogeneic bone-forming cell product.
Smoking linked to cervical degenerative disc disease
Whilst smoking has previously been connected with lumbar degeneration, this study has associated it with degeneration of the cervical spine.
Early rehabilitation after spinal cord injuries may lead to better functional...
Research has associated earlier rehabilitation with modest improvements in functioning and physical independence for patients suffering from spinal cord injuries.
EOS imaging obtains Innovative Technology status from the Korean National Evidence-Based...
This status categorises EOS as a unique modality, giving it a new reimbursement code with higher coverage than conventional X-rays.
DSM Biomedical appoints Eric Teutsch as president
Teutsch joins DSM from Stryker, where he was vice president and general manager of the Orthobiologics Division.
Amendia launches OmegaLIF expandable lumbar interbody device
The OmegaLIF is designed to provide a solution for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1.
Bone Therapeutics to combine Allob cells with Kasios’ spinal fusion cage
Bone Therapeutics is to extend its collaboration with Kasios. The companies aim to combine Bone Therapeutics' Allob cells with Kasios' spinal fusion cage.
Medovex receives reimbursement for DenerveX facet joint syndrome treatment in Germany
The new reimbursement coding, effective immediately, was released in the Diagnosis-Related Group system in 2016 in Germany. This coding allows for hospitals and outpatient centres to receive reimbursement for the use of the DenerveX System for the treatment of facet joint syndrome in the spine.
Agreement of cervical spine degenerative pathology findings in magnetic resonance imaging...
Researchers compared the inter- and intra-rated agreement of magnetic resonance imaging findings, and discovered that even inter-rated agreement ranged substantially, even in an idealised study setting.
RTI Surgical and Oxford Performance Materials to manufacture implants using OsteoFab...
Under the agreement, OPM will manufacture RTI's spinal implant designs using OsteoFab technology, and RTI will oversee finishing steps, packaging, marketing and distribution of finished products.
Two economic publications show sacroiliac joint surgery as cost-effective and money-saving
SI-Bone has announced that two economic studies show cost benefits for minimally invasive sacroiliac joint fusion surgery in the treatment of chronic sacroiliac joint dysfunction.
Wenzel Spine receives US Food and Drug Administration approval to market...
VariLift-LX is indicated to be implanted in a unilateral or bilateral capacity via a posterior or transforaminal lumbar interbody fusion interbody fusion approach, and may be used stand-alone, without supplemental fixation.
Leader Biomedical partners with BioTiss Austria to further develop eCOO technology...
Leader Biomedical Group has partnered with BioTiss, in order to consolidate human musculoskeletal tissue processing at their facilities in Austria.
NICE guidelines recommend infliximab for treatment of severe ankylosing spondylitis
The guidelines recommend infliximab for use within its marketing authorisation, as a potential treatment in adults whose disease has not responded adequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs.
InVivo Therapeutics INSPIRE study names University of California, San Diego Medical...
Joseph Ciacci, clinical professor of Surgery at the UC San Diego School of Medicine and chief of Neurosurgery at the Veteran Affairs San Diego Healthcare System, has been named principal investigator at the site.
TranS1 names Chris Groppa chief marketing officer and director of reimbursement
Groppa will oversee the company's marketing activities, and will continue to oversee its US insurance reimbursement strategy.
Feasibility of individualised metal 3D printed spinal implants demonstrated in Metalysis...
Spinal joint replacement patients could potentially receive individualised, metal 3D-printed implants, thanks to research partnership Metalysis and TWI.
Exactech acquires independent distribution partner Exactech Australia
The purchase included all the stock and assets of Exactech Australia, a Sydney-based importer and distributor of Exactech's orthopaedic implants, instrumentation and advanced surgical technology.
First implantation of Expanding Orthopedics FLXfit 3D expandable cage performed in...
Jonathan Lewin of North Shore Forest Hills Hospital in New York has become the first surgeon in New Jersey, USA to adopt the FLXfit articulated and lordotic expandable cage for the treatment of minimally invasive transforaminal lumbar interbody fusion surgery.
First Implanet Jazz band surgical procedure performed in Brazil
The first idiopathic scoliosis surgical procedure using the Jazz platform in Brazil has been successfully performed by Raphael Pratali and his team at the Hospital do Servidor Público Estadual in São Paulo, Brazil.
Updated clinical practice guidance issued on chiropractic care for low back...
The update, which revised and combined three previous guidelines, suggests that doctors of chiropractic are well-suited to diagnose, treat, co-manage and manage the treatment of patients with low-back disorders.
The mini-open pedicle subtraction osteotomy for flatback syndrome and kyphosis correction
Dean Chau and Darryl Larry demonstrate the technique of the mini-open pedicle subtraction osteotomy, in a video for an ahead-of-print article to appear in Operative Neurosurgery.
SpineGuard appoints Steve McAdoo as vice president of Business Development
McAdoo has more than 27 years of global marketing, sales management and business development experience in the medical device industry, including spine, general orthopaedics, trauma, cardiovascular and urology.
German Institute for Quality and Efficiency in Health Care publish report...
The aim of the report is to identify those recommendations from current guidelines of high methodological quality that may be relevant for the potential new disease management programme, "Chronic back pain".
CTL Medical acquires spinal implant designer and manufacturer, AccelSpine
The AccelSPINE brand will remain intact until the integration is complete, and all relevant regulatory measures have been met.
K2M Rhine cervical disc system receives CE mark
K2M has been granted CE marking for the Rhine cervical disc system, which can now be sold and distributed within Europe. This device is a next-generation product for the treatment of degenerative disc disease.
Centinel Spine’s Altos system cleared by FDA, first implantation performed
The US Food and Drug Administration (FDA) have cleared the Altos (Centinel Spine) posterior cervical thoracic stabilisation system. The product is indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine.
Interventional Spine to launch redesigned website
Interventional Spine is to launch a new, redesigned version of its website, which will feature the company's newly-released next-generation expandable lumbar cage system.
Precision insertion of sacroiliac screws using an augmented reality-based navigation system...
An experienced orthopaedic surgeon was able to successfully and accurately place percutaneous sacroiliac screws into a number of cadavers using a new augmented reality (AR) navigation system.
Exercise associated with prevention of low back pain
Exercise "alone or in combination with exercise "may reduce the risk of low back pain, suggests a review article published by JAMA Internal Medicine.
SpineGuard secures €7.7M debt financing with Bpifrance and IPF Partners
Spineguard has secured €7.7M of debt financing through an Innovation Loan of €1.5M with Bpifrance and the issuance of four tranches of bonds totaling €6.2M with IPF Partners.
Monitoring scoliosis patients’ brace use prevents curve progression, surgery
Adolescent scoliosis patients who used a brace with embedded sensors which monitored use wore their brace for longer than those who were not told the purpose of the monitors.
3D photography could improve assessment of chest wall deformity in scoliosis...
Plastic surgery's 3D imaging techniques could simplify and improve the assessment of deformity and the measurement of post-operative improvements in scoliosis surgery.
Motor control exercise may help lower back pain
Motor control exercise (MCE) has been developed with the aim of restoring the coordination, control and capacity of the trunk muscles that support the spine.
Study reveals new approach to low back pain diagnosis
A team from the Feinstein Institute for Medical Research, Manhasset, USA, have discovered a new, personalised approach to diagnosing low back pain. Their research has been published in Arthritis Research and Therapy.
SpinalCyte receives new patent for spinal disc tissue engineering
The technology described in the patent involves incorporating a three dimensional matrix to expose the fibroblasts to a mechanical strain using intermittent hydrostatic pressure and/or fluid shear stress.
Bill Hawkins appointed chairman of Bioventus’ board of managers
Bioventus has announced the appointment of Bill Hawkins, retired chairman and chief executive officer of Medtronic and currently lead director of Immucor, as its new chairman of the company's board of managers.
First surgical case performed successfully using K2M Cascadia lateral interbody system
This case "performed in the USA "follows the product's recent US Food and Drug Administration 510(k) and CE mark clearance.
Vexim SpineJack reaches 25,000 unit sales milestone
Vexim has reached the key milestone of 25,000 SpineJack units sold since the market launch of the implant in 2011.
Life Spine to offer PULSE program and cadaver workshops in 2016
Life Spine is to offer the Physicians Understanding the Life spine Experience (PULSE) program at their new medical facility and cadaver lab in Huntley, USA.
Medtech granted FDA 510(k) clearance for Rosa Spine
Medtech has been granted 510(k) clearance from the US Food and Drug Administration (FDA) to market the Rosa spine unit in the USA.
Nearly one in three adolescents report back pain
It is becoming more common for children and adolescents to seek medical care for back pain, according to a literature review published in the Journal of the American Academy of Orthopaedic Surgeons.
Spinal fractures may lead to widespread chronic body pain
Fractures of the spine and hip, among other bones, may lead to an increased risk of widespread chronic body pain later on in life, according to a new study published in Archives of Osteoporosis.
First spinal fusion surgery performed with “one-step” pedicle screw implantation using...
The world's first spinal fusion surgery performed with the one-step-insertion of pedicle "smart-screws", guided by SpineGuard's Dynamic Surgical Guidance (DSG) technology has taken place in Paris, France.
NuVasive to acquire Ellipse Technologies
Nuvasive is to acquire Ellipse Technologies for a $380 million upfront cash payment and a potential $30 million milestone payable in 2017 according to the achievement of various revenue targets.
InVivo Therapeutics granted approval to convert INSPIRE from pilot study to...
The study will now be formally known as "The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury."
Kentucky and Ohio, USA, Medicare Administrative Contractor to provide coverage for...
This coverage, which should give 2.8 million beneficiaries access to this surgery, will become effective on the 1st February 2016.
Use of opioid prescribing guidance significantly decreases prescription rates
Opioid prescribing guidance can have an immediate and long-lasting impact on opioid prescribing rates for minor conditions in an acute care setting.
K2M receives US FDA 510(k) clearance for Everest MI XT spinal...
K2M has also received CE mark for the system, which is a cannulated top-loading pedicle screw system featuring rigid closed-top break-off extension tabs, designed for minimally invasive rod passage.
ChoiceSpine Tomcat receives 510(k) clearance
This new device is designed to combine the functionality of two other ChoiceSpine products; Stealth and Falcon. It also uses PEEK-Optima HA Enhanced.
Teenager partners with K2M to design spinal implant for scoliosis
A teenager at Tufts University, Medford, USA has spent three years developing a titanium-alloy spinal implant for adolescents with scoliosis, which expands as the patient grows, according to a report in Qmed.
New generation of synthetic bone graft developed
A new kind of synthetic bone graft has been developed by a team at Queen Mary University, London. This bone graft boosts the body's ability to regenerate bone tissue.
Life Spine’s Gruve anterior cervical plate system receives 510(k) marketing clearance
This system is designed to allow for extreme bone screw angulation and large graft windows. It is due for release in 2016.
ApiFix connects North American parents with European spine surgeons using their...
ApiFix has begun connecting the parents of children in Australia, Canada and the USA who have adolescent idiopathic scoliosis (AIS) with spine surgeons in Europe and Israel currently using the ApiFix system to treat AIS.
Dyneema Purity radiopaque cerclage cable from DSM receives FDA 510(k) clearance...
The US Food and Drug Administration (FDA) has cleared DSM Biomedical's Dyneema Purity radiopaque cerclage cable for use in the treatment of spine fractures and other orthopaedic trauma.
Fiagon and joimax partner for Intracs system
This system combines the companies' surgical navigation and minimally invasive endoscopic spine surgery offerings.
Stimwave Freedom-8A spinal cord stimulation system receives FDA clearance
The Stimwave Freedom-8A spinal cord stimulation (SCS) system has been granted FDA clearance to be marketed for the relief of chronic back and leg pain.
Mazor Robotics Renaissance system receives 100th order
The system was purchased by UConn Health, located in Farmington, USA and installed at its John Dempsey Hospital.
EOS platform installed in record six hospitals over the last month
This brings the total current US installations of the imaging system to 47, with 7 further platforms shipped for installation.
FDA approves Infuse bone graft for three new spinal surgery indications
The new indications approve Infuse for use with certain spine implants made with polyetheretherketone (PEEK).
Novel tissue engineering strategies may provide better outcomes for lumbar disc...
Though these emerging biological repair methods still face challenges as they advance to and through clinical testing in patients, they may be able to offer significant pain reduction and restore flexibility and motion of the spine.
Rosa robotic surgery systems sold to two US hospitals
Medtech has sold two new Rosa robotic surgery systems to the Children's Hospital of Atlanta and the Children's Hospital Colorado, both in the USA.
Long posterior cervical fusions can be stopped at C7 instead of...
Multilevel posterior cervical fusions can be safely stopped at C7, rather than the upper thoracic spine, without increasing the risk of complications or subsequent fusion extension at short- to mid-term follow-up.
Positive results of ReActiv8-A clinical trial confirmed by additional data
Additional data from 13 subjects has been released by Mainstay Medical, showing significant and lasting improvements in pain, disability and quality of life.
Most children and adolescents with lumbar disc herniation present with malformations...
Results published in Neurosurgery also suggest that surgery on the disc alone, without spinal fusion, may be sufficient to treat low back pain from herniated discs in young people.
Artificial lumbar disc effective at 11-year follow-up
In the short- to mid-term, lumbar total disc replacement has at least equivalent clinical results compared with lumbar fusion. However, questions remain regarding long-term complications effectiveness.
Two-level cervical disc arthroplasty is an effective alternative to ACDF at...
A study has shown that the procedure can offer an earlier return to work and fewer reoperations treatment by ACDF.
Swedish group report substantial long-term pain following lumbar fusion for chronic...
The report indicates that although lumbar fusion can still be considered a valid treatment option for chronic low back pain, substantial postoperative pain and disability should be expected.
Bioventus acquires BioStructures, receives entire product portfolio
The BioStructures product portfolio includes synthetic, allograft, collagen, and demineralised bone matrix options for surgeons.
St Jude Medical launches spinal cord stimulation system in Europe
The Proclaim Elite SCS system is an upgradeable, non-rechargeable, burst-enabled MR-conditional SCS system.
The evolution and present role of percutaneous pedicular screw fixation in...
Minimally invasive surgery is beneficial in a well-selected group of MSD patients suffering from clinically significant instability with intractable back pain or motor deficits, Naresh Kumar tells Spinal News International.
Secukinumab receives European Commission for the treatment of ankylosing spondylitis
This decision makes the drug the first new treatment advance for ankylosing spondylitis in 16 years.
Leader Biomedical Group expands operations to Brazil
Leader Biomedical group supplies a number of bone graft substitutes processed with its eCOO technology, including the eTiss demineralised bone matrix.
Stem cell treatment protects against harmful immune response after spinal cord...
The findings, which will be published online in Scientific Reports resulted in significant improvements in the motor and urinary functions of animals.
Allograft bone not reliable for atlantoaxial fusion, even with use of...
A study from Honghui Hospital, Xi'an, China, confirmed autograft as the gold standard for atlantoaxial fusion, in spite of its higher rate of donor-site morbidity.
Children with certain neuromuscular disorders three times more likely to experience...
This research from the Johns Hopkins Children's Center shows children with cerebral palsy, spina bifida, and muscular dystrophy, are most at risk.
DT Elite guide system launched by Nexxt Spine
This system is designed to reduce the number of surgical steps required during an anterior cervical discectomy and fusion procedure.
Electrical stimulation therapy could relieve lower back pain in older adults
A study from the University of Florida has shown that higher dosage is required to achieve relief in older patients.
‘No evidence’ that bone-growth agent for spinal fusion increases cancer risk
A new study has found no significantly higher risk of cancer in patients who underwent lumbar spinal fusion surgery using rhBMP than in the general population.
AxiaLIF procedure saves US$3,500 compared to TLIF procedure, according to economic...
As well as financial savings, the procedure was associated with shortened hospital stays, lower rates of hospital readmission, and a faster return to work.
More than 50 surgeons trained in minimally invasive BoneScalpel platform at...
More than 50 surgeons trained in minimally invasive BoneScalpel platform at the conference in Las Vegas, USA.
Pessimism and a lack of exercise is “a risky combination”
Anne Mannion and Achim Elfering discuss their research, which evaluates the longitudinal validity of beliefs in predicting future pain in the shoulders, neck and back. They consider if cognitive behavioural interventions, education and exercise programmes could serve to reduce the impact of back pain in high-risk groups.
iFuse system receives new indication cleared by the FDA
The indication includes improved pain, patient function and quality of life at 12 months.
Preliminary report on the PROlif Lateral solution presented by Mazor Robotics
The procedure was also shown at the SMISS conference for the first time on a cadaver.
Updated design of Interventional Spine’s Opticage receives FDA clearance
The expandable interbody fusion device has received clearance for spinal fusion.
EOS imaging system to be installed at Kudanzaka Hospital in Japan
The platform will be available to more than 1,000 patients per year undergoing spine surgeries in Japan.
Medicare outpatient and physician payments to increase for minimally invasive sacroiliac...
These proposed payments represent an increase of 14% for outpatient payment and 25% for physician reimbursement, and will become effective on January 1, 2016.
Acupuncture and Alexander Technique prove effective in long-term treatment of chronic...
In a study published in Annals of Internal Medicine, both treatments have been shown to lead to significant reductions in neck pain and associated disability, compared with traditional care alone.
CE mark application for Mainstay Medical’s ReActiv8
Mainstay Medical has submitted a CE mark application for its ReActiv8 implantable neurostimulation device, which is designed to treat disabling chronic low back pain.
Revision surgery more cost-effective than primary surgery for adult spinal deformity
Revision surgery for adult spinal deformity has been shown to incur significantly lower surgical costs than primary surgery. In a study from Johns Hopkins, Baltimore, USA, which calculated cost-effectiveness in terms of quality-adjusted-life-years (QALYs), revision surgery was also shown to have a lower overall two-year cost and higher QALY gains, although these results were not significant.
Minimally invasive implant procedure shown to be highly effective in treatment...
A clinical trial featured in the November issue of Neurosurgery has shown that minimally invasive sacroiliac joint fusion using triangular titanium implants is highly effective in reducing pain and disability for patients with sacroiliac joint (SIJ) dysfunction.
Muscle relaxant or opioid combined with naproxen does not improve low...
According to a study in the Journal of the American Medicine Association (JAMA), patients with acute low back pain (LBP) achieved no greater pain relief of improvement in functional outcomes when treated with naproxen combined either a muscle relaxant or opioid, than with naproxen combined with a placebo.
Differences in TLIF and posterolateral fusion outcomes limited in terms of...
A study from Norton Leatherman Spine Center, Louisville, USA, has shown that, while TLIF (Transforaminal lumbar interbody fusion) may generate better one-year ODI (Oswestry disability index) outcomes for spondylolisthesis, it may not produce any other significantly better outcomes than posterolateral fusion (PSF).
Misonix introduces new BoneScalpel MIS platform and trains 120 surgeons at...
Surgeons who attended Misonix's presentations at the conference received hands-on training through peer-to-peer demonstrations of the new platform.
Failure of short lumbar fusions may be related to spino-pelvic malalignment...
It is suggested that restoration of spino-pelvic alignment in short lumbar fusions may reduce the risk of revision surgery for adjacent segment disease. Although prospective clinical data is currently lacking, this finding is supported by biomechanical data.
Manny Avila appointed as new IlluminOss chief executive officer
IlluminOss Medical has named Manny Avila as its new chief executive officer. Avila has worked in medical device sales, operations and business managements for over two decades.
Seaspine announces new Cambria NanoMetalene cervical interbody fusion device.
The device is an "ultra-thin" layer of commercially pure titanium, molecularly bonded to a PEEK-Optima implant. It is designed for use as an adjunct to fusion in patients with degenerative disc disease, and for use in anterior cervical discectomy procedures.
Nanovis announces new Forticore wedge-shaped Iorditic cervical cage and TLIF device
FortiCore implants, comprised of a PEEK centre and a deeply porous titanium scaffold, are the most scientifically advanced interbody fusion devices, according to Nanovis.
Stryker’s VertaPlex HV becomes first PMMA to receive clearance for treating...
Stryker Corporation's Interventional Spine business has been granted FDA clearance to market its VertaPlex HV for the treatment of sacral insufficiency fractures.
Life Spine launches four minimally invasive systems at NASS
Life Spine has revealed four new products at the 2015 North American Spine Society meeting in Chicago.
SpinalCyte granted new Australian patent for spinal disc tissue engineering
SpinalCyte has announced the issuance of Australian Patent No. 2013257540, "Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor." This adds to the 11 US and foreign patents issued and directly owned by the company.
joimax launches EndoLIF on-cage and iLESSYS Delta Interlaminar System
joimax has launched a 3D-printed titanium alloy - the EndoLIF On-Cage - and its iLESSYS Delta interlaminar system, at the 30th annual North American Spine Society meeting in Chicago.
Expedium Verse Spinal System simplifies spinal surgery according to DePuy Synthes
This product " an all-in-one pedicle screw system " could enable surgeons to perform multiple spinal correction manoeuvres during spinal fusion surgery with a single implant type and fewer instruments than can traditional pedicle screw systems.
Zeniva PEEK enables breakthrough intervertebral joint fusion technology, claims Solvay
Rather than coating the fusion device, this surface treatment is grown directly from the bulk PEEK material of Vertera Spine's Cohere system. Solvay's Zeniva PEEK is made up of both the porous surface technology and the device on which it is grown.
Benvenue Medical announces commercial availability of Luna 3D Interbody Fusion System
Benvenue Medical has announced the US commercial launch of their Luna 3D Interbody Fusion System, which it claims provides this least invasive approach to spinal fusion for treatment of symptomatic degenerative disc disease
4WEB Medical announces launch of 3D-printed Posterior Spine Truss System
The US market launch of the Posterior Spine Truss System by 4WEB medical has been announced at the North American Spine Society annual meeting in Chicago. This system is a line of interbody fusion devices with applications across posterior spine approaches including PLIF, TLIF, and Oblique procedures.
Prestige LP cervical disc patients maintain improved outcomes at seven years
Medtronic has announced favourable seven-year data maintaining improved clinical outcomes and patient satisfaction for the Prestige LP cervical disc compared to anterior cervical discectomy and fusion (ACDF).
Patients’ expectations of surgical outcomes need to be more realistic
According to a new study presented at the 30th Annual Meeting of the North American Spine Society, 87% of lumbar spine surgery patients had more optimistic expectations of surgical outcomes than their surgeons did.
Simplify Disc receives IDE approval from the FDA for a two-level...
Simplify Medical has announced that it has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a two-level clinical trial comparing its Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. This IDE approval grants Simplify the option of expanding its clinical operations.
Providence Medical Technology launches proprietary surface technology which it claims can...
Cavux, which is designed to speed bone fusion during the healing process, has been introduced by Providence Medical Technology. It is a surface technology that produces micro-textures on titanium surfaces, using micro- and nano-textures created across the implant surface area serve to enhance the fusion process.
Study compares results of allograft and autograft bone use and measurement...
According to a new study presented at the 30th Annual Meeting of the North American Spine Society (NASS; 14-16 October, Chicago, USA), spine surgeons should choose a patient's own bone material rather than donor bone for better results in posterior atlantoaxial fusion.
NuVasive receives first FDA 510(k) clearance of cervical corpectomy cage
The X-Core Mini cervical corpectomy system is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure.
High rate of complications following adult deformity surgery may not ultimately...
Many complications "likely have minimal or no impact on ultimate patient outcome," according to Justin Smith, professor of Neurosurgery at University of Virginia Medical Center, Charlottesville, USA, who presented the findings at EUROSPINE 2015.
Treatment with more than two cages in deformity surgery improves outcomes
Using more than two cages in adult spinal deformity patients produces significantly better correction, clinical outcomes and significantly fewer neurological complications, according to data shared at EUROSPINE 2015.
Robert Gunzburg followed in the footsteps of his father and grandfather in becoming a doctor. Breaking with the family tradition of rheumatology, Gunzburg decided to specialise in spinal medicine. He told Spinal News International about his path to and what he has learned from his journey so far.
Percutaneous osteosynthesis in bone cancer patients
Percutaneous osteosynthesis consists of inserting screws into bone structures through a skin incision of less than 10mm. It is now performed percutaneously by interventional radiologists due to the development of cannulated screws inserted coaxially over a guide pin, and due to the level of accuracy possible with CT- or flat panel-guidance, writes Frédéric Deschamps.
Treating compression fractures with Vessel-X
Vessel-X (Spirit Spine) is a device used to undertake "vesselplasty" procedures, designed to restore vertebral body height following a vertebral compression fracture using a non-stretchable PET (polyethylene terephthalate) container.
ECA Medical Instruments disposable fixation kit used in first surgery with...
ECA Medical Instruments' custom disposable instrument kit was used to successfully secure the first Revolution spine system lumbar implant from Intelligent Implant Systems (ISS).
Atlas Spine Launches True Position XL TLIF platform and 36mm surgical...
Supported by the advanced TruLIF technique, Atlas Spine says that its family of True Position XL implants ranging from 36-51mm in length exceeds current TLIF offerings and provides implants comparable to anterior lumbar interbody fusion/lateral footprints using a posterior approach.
Life Spine announces limited release of SImpact sacroiliac joint fixation system
The SImpact system consists of two unique diameter cannulated implants offered in various lengths, in full and partially threaded configurations to accommodate variations in patient anatomy.
Alphatec Spine launches Neocore osteoconductive matrix in the USA
The first patient surgical implantation of the Alphatec Neocore osteoconductive matrix "a synthetic scaffold for the regeneration of bone "has been successfully completed.
NuVasive Spine Foundation exceeds US$18m in global effort to support spine...
The NuVasive Spine Foundation (NSF), a non-profit organisation founded and managed by the company, has reached a cumulative milestone of approximately US$18.4m contributed since the Foundation’s inception in 2009.
SpineGuard receives CE mark for new application of its disruptive Dynamic...
SpineGuard has announced the CE marking for its DSG (Dynamic Surgical Guidance) Threaded Drill and the first surgery, a thoracolumbar scoliosis correction, in Lille's Centre Hospitalier Universitaire by Assaker, Chopin and Allaoui.
“Remarkable” rate of heterotopic ossification after 10 years in cervical disc...
Although cervical total disc replacement remains a safe and effective procedure with low rates of complication and high levels of patient satisfaction, in patients with adjacent segment degeneration, significant heterotopic ossification and resulting loss of prosthesis function was observed at 10 years' follow-up.
Gelatine matrix with human thrombin can reduce intraoperative blood loss
A study presented at EUROSPINE 2015 (2-4 September, Copenhagen, Denmark) exhibited success using Gelatine matrix with human thrombin to reduce intraoperative blood loss alongside traditional haemostasis techniques.
MedTorque releases new TRI-GEAR ratcheting instruments for spine surgery
MedTorque has released its new line of TRI-GEAR silicone handle ratcheting instruments for use in spine surgeries.
Treating gunshot injuries to the spine
Jay M Zampini discusses how best to treat gunshot injuries to the spine "the third most common cause of spinal cord injury in the USA.
EOS imaging acquires exclusive rights to scoliosis progression prognosis software technology
Eight international EOS centres will undertake a multicentre study to evaluate the technology as a predictive tool.
Stryker Navigation introduces SpineMask tracker and SpineMap 3D 3.0 software
SpineMask Tracker is a non-invasive patient tracker enabling minimally invasive approaches for spine surgery without an additional incision for navigation tracking.
New Jazz Band FDA clearance expands posterior fixation system selection
Jazz may be used with other posterior thoracolumbar fixation systems (screws, rods, hooks) available on the market.
Medtech closes sale of Rosa robotic surgery system in Germany
Medtech has announced a new sale of its Rosa robot to Frankfurt University Hospital in Germany.
Spinal Elements receives expanded indications for the Lotus posterior cervical/thoracic spinal...
The new clearance now broadens Lotus' indications for the placement of screws in the cervical (C1-C7) spine, providing surgeons with more surgical treatment options for improved treatment of various posterior cervical and thoracic pathologies.
FDA approval for Precision Spine’s Reform modular and HA-coated pedicle screw...
The Reform system represents the first modular system on the market to feature a cobalt chrome tulip with a proximal tapered triple lead thread, designed to help increase the bone/screw interface to enhance pull-out strength and allow for efficient screw delivery.
Patients prefer relief from lower back pain over improved mobility
A new study published in Neurology has found that when asked to choose between treatments that reduced pain or those that would help them stand or walk, lumbar spinal stenosis patients overwhelmingly chose pain relief.
Cervical deformity surgery produces a 43% early complication rate
Forty-three per cent of cervical spine deformity patients experience early complications following surgery with 24.4% of patients experiencing major complications, according to a presentation at EUROSPINE 2015 (2-4 September, Copenhagen, Denmark).
VA Spinal Cord Injury Center demonstrates clinical improvement with EarlySense monitoring...
The EarlySense system monitors patients’ heart rate, respiratory rate and motion on a continuous basis, through a contact-free sensor under the mattress, or within a cushion of a chair.
Radiolucent pedicle screw system offers alternatives for spinal tumour patients
icotec's carbon/PEEK spinal system offers radiotherapists, spinal surgeons and patients artefact-minimised planning and optimised application of radiation therapy to treat spinal tumours.
INSITE data indicate efficacy of minimally invasive sacroiliac joint fusion
Peter Whang discusses recent results from the INSITE trial, which compares the use of minimally invasive sacroiliac joint fusion using iFuse implants (SI-Bone) with non-surgical management to treat chronic sacroiliac joint dysfunction.
Titan Spine partners with MBA to expand European reach of Endoskeleton...
Under the agreement, Titan Spine will provide its spinal interbody fusion devices featuring its proprietary surface technology to MBA for distribution in Spain, Portugal, Andorra, Luxembourg, Belgium and the UK.
NuVasive to launch Integrated Global Alignment platform for select international markets...
Company to present technical exhibit and host workshop focused on achieving more precise spinal column alignment.
OsteoMed Spine launches the PrimaLIF lumbar lateral interbody fusion system
With the smallest initial diameter and five slim blade design, PrimaLIF LLIF provides "simplicity and security surgeons are looking for in a lateral system" according to an OsteoMed press release.
Signus launches the Diplomat pedicle screw system
Developed in cooperation with international spine experts, the Diplomat system is a posterior fixation system that provides user-friendly and reliable instrumentation for all spine treatments.
Providence Medical Technology announces new financing of US$12m
As well as its new financing, the company has also announced the appointment of Jason Hoffman as vice president of global sales.
Amedica introduces the Valeo II lateral lumbar interbody fusion device system
The Valeo II is indicated for intervertebral body fusion of the spine in skeletally mature patients and is designed for use with autograft to facilitate fusion.
SI-Bone announces three publications on iFuse use for minimally invasive sacroiliac...
Results from prospective clinical trials demonstrate early and marked improvements in pain, disability and quality of life achieved at six months, which are sustained at one year.
New method for closing scoliosis surgery incision nearly eliminates all infections
The new technique reduces complication rates for complex cases where patients are most at risk of infections.
Remedy Pharmaceuticals initiates phase 2A study of Cirara in spinal cord...
Data from preclinical and human clinical studies has suggested that Remedy Pharmaceuticals' drug candidate, Cirara, inhibits spinal cord oedema and micro haemorrhage formation.
A quarter of US patients prescribed opioids progress to longer-term prescriptions
New research found that a quarter of patients progressed to long-term prescription, and that patients with histories of tobacco use and substance abuse were likeliest to use opioid painkillers long-term.
SeaSpine launches Ventura NanoMetalene interbody device
Ventura NanoMetalene, which is commercially available and has been successfully implanted, is indicated for use as an adjunct to fusion in patients with degenerative disc disease.
Zyga receives 510(k) clearance for SImmetry sacroiliac joint fusion system updates
The new procedural option allows surgeons to perform sacroiliac joint fusion through a single incision.
Prestige LP artificial cervical disc produces fusion-equivalent 24-month outcomes
Outcomes associated with Medtronic's Prestige LP artificial cervical disc are at least non-inferior to anterior cervical discectomy and fusion (ACDF) outcomes at 24 months, according to a new study published by the Journal of Neurosurgery: Spine.
Hyun Bae began his medical studies at Columbia University, where he graduated with a degree in biomechanics. Having interacted with numerous medical students in Columbia's orthopaedics lab, he decided that orthopaedic medicine was the career path he wanted to follow.
Paradigm shift in blood management for surgery in metastatic spine diseases
Surgery for metastatic spine diseases is potentially complex, often requiring complex reconstruction resulting in prolonged operative times, leading to significant blood loss, writes Naresh Kumar.
The move towards nonopioid pain management
The high prevalence of opioid related adverse events and costly consequences to our society has prompted many to critically look at our practice of outpatient opioid prescription, writes Matthew J McGirt.
Paralysed men move legs with new non-invasive spinal cord stimulation
Five men with complete motor paralysis were able to voluntarily generate step-like movements thanks to a new strategy that non-invasively delivers electrical stimulation to their spinal cords.
Elderly spinal deformity patients recover from surgery significantly faster than younger...
A new study has come to the unexpected conclusion that elderly adult spinal deformity patients who undergo surgery recover significantly quicker than their younger counterparts. The study was published by the journal Spine.
NuVasive announces US settlement
Under the terms of the settlement agreement, the company will pay US$13.5m, plus fees and accrued interest.
Bacterin acquires X-spine Systems to create Xtant Medical
Bacterin International has purchased the outstanding shares of X-spine Systems in exchange for approximately 4.24 million shares of Bacterin common stock and approximately US$60m in cash.
Bracing for idiopathic adolescent scoliosis produces similar quality of life scores...
The study, led by Ane Simony, University of Southern Denmark, Denmark, and published by Scoliosis is one of very few studies focusing on long-term outcomes of brace treatment.
Minimally invasive lumbar laminotomy has no functional benefits at six or...
A new study published by The Spine Journal suggests that a minimally invasive approach produces no significant functional benefits when compared with a more traditional open procedure.
Spines of boys and girls differ at birth
The difference between genders aids in childbearing, but likely imparts a greater susceptibility for scoliosis and osteoporosis in females.
Centinel Spine implants first Stalif Midline II-Ti device
Centinel Spine has implanted its first two Stalif Midline II-Ti devices at Texas Health Plano, Plano and Florida Hospital Carrollwood, Tampa, USA.
Disc regeneration using embryonic stem cells
Clarkson University professor Thomas Lufkin, Bayard and Virginia Clarkson Endowed Chair of Biology, is working to reprogramme embryonic stems cells to become the fibrocartilage that separates the vertebrae.
Oxford Performance Materials receives FDA clearance for its SpineFab vertebral body...
OPM’s SpineFab device is a vertebral body replacement intended for use in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumour or trauma.
Chronic opioid therapy diminishes lumbar fusion outcomes in workers’ compensation patients
Extended opioid therapy following lumbar fusion surgery for US workers' compensation patients is associated with worse outcomes, a new study has found.
Clinical study shows advantages of sterile single-use instrumentation for lumbar fusion
A retrospective clinical study indicates that Safe Orthopaedics' Sterispine system results in reduced postoperative infection, morbidity and mortality.
Former professional rugby players have greater cervical spine degeneration than the...
Researchers have used clinical examinations and magnetic resonance imaging (MRI) studies to determine whether retired professional rugby players experience more serious symptoms of cervical spine degeneration than the general population.
Musings of an octogenarian surgeon
In the context of the spinal surgery profession, the experienced surgeon has gained wisdom through experience, and is now ready to impart it to younger colleagues, writes Robert Mulholland.
Spinal manipulation for acute and sub-acute low back pain
According to Michael Schneider, the majority of patients with an acute episode of low back pain will not have any serious spinal abnormality or disease as the cause of their symptoms. Of these patients who seek treatment, most will be told they have non-specific mechanical back pain.
EOS imaging announces first US bracing facility installation
EOS imaging has completed the installation of an EOS imaging system at National Scoliosis Center, a Virginia-based scoliosis treatment clinic.
Orthopaedic and neurosurgeons produce similar spinal surgery outcomes
Spine surgeons, regardless of speciality, seem to achieve equivalent outcomes in mortality, 30-day readmission and surgical site infection rates, according to a new study, although there were notable differences in blood transfusion rates.
Removing outer surgical gloves may reduce spinal surgery infections
A study published by the Journal of Spinal Disorders and Techniques may provide a relatively simple method of reducing postoperative spinal surgery infections.
Potential risk factors for recurrence of low back pain identified
A new study has examined risk factors for recurring low back pain, identifying disc degeneration, the presence of high intensity zone and the number of previous episodes as potentially important risk factors.
Captiva Spine’s TowerLOX pedicle screw system receives clearance for enhanced rod...
Captiva Spine has received 510(K) clearance from the US Food and Drug Administration (FDA) to market its enhanced TowerLOX minimally invasive pedicle screw system.
Substantial reduction of adolescent idiopathic scoliosis curvature at one-to-three years with...
The ApiFix system, which has now been used to correct scoliosis in 50 adolescents since the system was approved for marketing in Europe, has continued to demonstrate encouraging results at one-to-three years of follow-up with 25 patients.
Stryker Spine Launches LITe ALIF Procedural Solution
Stryker Spine has announced the launch of the LITe (Less Invasive Technologies) anterior lumbar interbody fusion (ALIF) Procedural Solution.
CollPlant executes non-binding term sheet to develop and commercialise an absorbable...
The new matrix is composed of CollPlant’s type 1 recombinant human collagen and synthetic minerals that mimic bone structure, and may be used in combination with bio-functional molecules.
Rivanna receives FDA clearance of its Accuro device
Accuro provides untethered ultrasound imaging to automatically guide spinal anaesthesia with additional indications for ultrasound imaging of abdominal, musculoskeletal, cardiac, and peripheral vascular anatomies.
Misonix launches faster SonicOne ultrasonic debridement procedure
The procedure is enabled by a single-use disposable debridement probe with increased ultrasonic amplitude that allows surgeons using the SonicOne to potentially reduce operating room time by up to 50%.
DeGen Medical launches F1 MPS modular pedicle screw system
The system addresses a range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods and allows the surgeon intra-operative flexibility for bone grafting and screw placement.
New report suggests solutions to the financial burden of employee low...
The report looks at the effects of back pain in the workplace, as well as some of the proactive steps employers can take to reduce low back pain, including the implementation of gamification treatment to employee wellness programmes.
Pfizer begins phase 2b study of Staphylococcus aureus vaccine in adults...
The purpose of the study, named STRIVE, is to evaluate the safety and efficacy of the vaccine to determine if it prevents postoperative invasive S aureus infections in patients undergoing elective spinal surgery.
Avoid misconceptions by educating patients and restoring the doctor-patient relationship
Cheerag Upadhyaya, Kate W-C Chang, Donald Tomford and Lynda J-S Yang discuss the evolution of the doctor-patient relationship, and what physicians can do re-establish a bond that has long comforted and healed patients.
Medtronic announces global launch of the CD Horizon Solera Voyager spinal...
The system expands upon the transforaminal lumbar interbody fusion procedure by offering multiple, minimally invasive rod insertion options and enabling a seamless 3D-navigated surgical experience.
Safe Orthopaedics releases the Auto-Adjust pedicle screw system
Safe Orthopaedics has announced the first use of its new Auto-Adjust pedicle screw in surgical procedures to repair thoracic and lumbar spine fractures.
ECA Medical Instruments develops single-procedure ratchet to reduce time and cost...
Disposable ratchet to provide surgeons in hospital and outpatient settings with a versatile instrument in sterile ready package that will shorten spine implant surgery times.
InVivo Therapeutics reports significant improvement of two Neuro-Spinal Scaffold patients
One patient has regained sacral sensation with improved bladder function and the other demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side.
Spineology introduces ACT MediaLIF platform for minimally invasive spine surgery
Platform includes full US release of new Fortress pedicular fixation system and Medius midline retractor system.
Older patients with traumatic spinal cord injuries less likely to get...
Time between injury to arrival at an acute care centre was roughly twice as long for older patients than younger patients.
K2M launches the Mesa 2 deformity spinal system in the USA
K2M has announced the US commercial launch of the Mesa 2 deformity spinal system, the company's next-generation pedicle screw system designed to address the most complex spinal pathologies.
Globus Medical announces Rise-L expandable lateral interbody fusion device
Rise-L is a vertically-expanding LLIF device designed to minimise impaction, maximise indirect decompression, and provide a large graft space optimal for fusion potential.
SpineGuard obtains regulatory clearance to sell PediGuard in China
The China spine market has become the second-largest market in spine after the USA and is projected to be worth over US$1bn by 2019.
Vertebroplasty and kyphoplasty equally effective in reducing vertebral compression fracture pain...
A new study suggests that even though kyphoplasty is performed more frequently than vertebroplasty, the two procedures are equally effective in reducing pain and disability in vertebral compression fracture patients.
US lumbar posterolateral fusion procedure costs are lowest in the Midwest...
The Midwest recorded the lowest cost for PLF with the highest costs in the Northeast, and that the cost of procedures correlated with the average cost of living in each state, though not with the state's total population, according to a new study.
Centinel Spine is granted the first cervical multilevel indication for its...
The Stalif C product family had been previously cleared for use in conjunction with autograft or allogeneic bone graft at a single level in patients with degenerative disc disease of the cervical spine.
Medtech announces first sale of Rosa Spine robot in Europe
The first Rosa Spine robot was purchased by Amiens University Hospital in Amiens, France, a centre for the treatment of brain and spine disorders.
Zimmer completes combination with Biomet
Following the receipt of US Federal Trade Commission clearance, Zimmer has completed the acquisition of Biomet in a cash and equity transaction currently valued at approximately US$14bn.
Reducing radiation exposure during spine surgery
Radiation exposure due to the use of image intensifiers during spine surgery remains a significant source of potential harm for both patients and surgeons with potential long-term health issues such as cancer, suggests Sebastian Decker.
Wenzel Spine publishes positive clinical results for VariLift system
The paper, published in Medical Devices: Research and Evidence, provides an in-depth analysis of the VariLift system's design rational, functionality, and retrospective clinical results.
Signus launches the Ascot cervical plate
Along with Tosca and Tosca II Standard, Ascot is a new system that is now available in the USA, Europe and Australia for anterior stabilisation in interbody fusion.
Nanovis Spine receives FDA 510(k) clearance of its FortiBridge cervical plating...
Nanovis Spine's FortiBridge cervical plates are designed to complement the Nanovis' FortiCore cervical interbody implant system.
One third of adult spinal deformity patients experience implant-related complication
A study, published by the journal Spine, also found that just over one-half of patients suffering complications required a re-operation within two years of surgery, significantly affecting quality of life scores.
Smoking inhibits spinal cord healing following surgical treatment of cervical myelopathy
A study published ahead-of-print by the journal Spine suggests that smoking may have a directly toxic effect on the healing capability of the spinal cord, particularly if the patient in questions is a heavy smoker.
DePuy Synthes companies announces five-year cooperation agreement with the AO Foundation
DePuy Synthes and the AO Foundation have been working together since 1960 to deliver professional education and develop new innovations that improve patient outcomes and increase efficiency of care.
Aesculap receives FDA approval for the activL artificial disc for one-level...
activL is the first lumbar artificial disc with a mobile ultra-high molecular weight polyethylene core that supports both controlled translational and rotational movement similar to the movement of the healthy lumbar spine.
Implanet enrols first patient in a major multicentre clinical study led...
Implanet has enrolled the first patient in a multicentre clinical protocol designed to study the medical value provided by the JAZZ Band in the treatment of instrumented thoracic and lumbar arthrodesis.
Centinel Spine granted allogeneic bone graft indication for its anterior lumbar...
Centinel Spine has been granted clearance by the FDA for its STALIF Midline, Midline II and Midline II-Ti (Ti-Active) devices for use with allogeneic bone graft in lumbar spinal fusion procedures.
Aurora Spine launches minimally invasive Vox lateral interbody system with TiNano
Vox is Aurora Spine's modern, minimally invasive lateral lumbar interbody fusion system featuring TiNano titanium spray coating technology, which will allow for bone ongrowth due to its porous structure.
FDA advisory committee panel not required for i-FACTOR premarket approval
An advisory committee panel meeting will not be required for the final review of the premarket approval application for i-FACTOR peptide enhanced bone graft.
ApiFix reaches 50-patient milestone with its minimally invasive adolescent idiopathic scoliosis...
ApiFix has announced that the company's minimally invasive ApiFix system has now been used to correct scoliosis in 50 adolescents since the system was approved for marketing in Europe.
Spine Journal 2015 Outstanding Paper: Basic Science
At the annual meeting of the North American Spine Society (NASS, 12-15 November 2014, San Francisco, USA), Neil D Broom and Samantha A Rodrigues presented a paper on the annulus-endplate anchorage system and its mechanisms of failure.
The use of photographs can improve patient satisfaction following scoliosis surgery
Akif Albayrak writes that the use of pre- and postoperative patient photographs allows scoliosis patients a better perspective of surgical impact, thus enhancing their satisfaction with the treatment.
Stimwave receives FDA approval for IDE trial of Freedom system
Stimwave's trial will enrol 80 patients Freedom spinal cord stimulation system, which is based on an injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves.
joimax launches iLESSYS Delta system for treatment of spinal stenosis at...
The iLESSYS Delta is suitable for dorsal and dorso lateral treatment of central spinal canal stenosis and enables a large area to be decompressed by means of the interlaminar access, guided by endoscopic-assisted vision.
Overall rate of US traumatic spinal cord injury remains stable
Between 1993 and 2012, the incidence rate of acute traumatic spinal cord injury remained relatively stable in the USA, although there was an increase among older adults, mostly associated with an increase in falls, according to a study in JAMA.
StemCells commences second cohort of the Pathway study in cervical spinal...
The phase II study is designed to assess the potential of human neural stem cells to restore motor function.
InVivo Therapeutics announces enrolment of third patient in pilot spinal cord...
A third patient has been enrolled in InVivo Therapeutics' ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury at the Carolinas Medical Center, USA.
Intelligent Implant Systems announces US Patent for Revolution spinal system
Revolution is based on improving the thoraco-lumbar spinal fusion implant procedure by eliminating complicated reusable non-sterile instrument trays and replacing them with one easy-to-use disposable instrument tray.
Expanding Orthopedics announces the 100th implantation of FLXfit 3D expandable cage
Dom Coric of Carolina Neurosurgery and Spine Associates, Charlotte, USA, has successfully implanted Expanding Orthopedics' 100th FLXfit, an in-situ articulating with lordosis correction cage.
ApiFix elects Ted Bird as chairman of the board
Bird is chief development officer at the Medical University of South Carolina Institute for Applied Neurosciences, USA. Previously, he was president of Orthofix Spine Fixation.
Misonix introduces new 25mm BoneScalpel blade
The BoneScalpel is an ultrasonic bone-cutting instrument that provides surgeons a clean, controlled bone incision and removal that is also soft-tissue sparing.
Preoperative patient anxiety and depression reduces impact of cervical radiculopathy surgery
Martin Skeppholm told delegates at the Cervical Spine Research Society European Section meeting that patients with preoperative anxiety and depression see worse self-assessed outcomes following cervical radiculopathy surgery.
NASS recommends positive coverage policy for iFuse sacroiliac joint fusion
The coverage policy is based on 19 clinical studies, from which the committee concluded that the sacroiliac joint is an established source of chronic low back and that joint fusion has proven to be relatively safe.
FDA approves ViMove for expanded use in the USA
This expanded functionality and labelling permits the use of ViMove to display lower back and pelvic range of motion from healthy patients for the first time in the USA.
Michael Fehlings was encouraged to enter the medical profession by his grandfather. He cites the intellectual and technical challenges of neuroscience and precise surgery combined with the ability to help individuals as his role's most appealing aspects.
VertiFlex receives FDA PMA approval for Superion interspinous spacer
The US Food and Drug Administration (FDA) has issued a pre-market approval (PMA) order for Vertiflex's Superion interspinous spacer system, clearing the way for commercialisation in the USA.
Study suggests that Benvenue Medical’s Kiva system offers cost and resource...
Pain Physician journal publishes results showing lower risk for adjacent-level spine fractures and fewer reoperations with Kiva system.
NuVasive appoints Gregory T Lucier as chief executive officer
Lucier, who has been serving as interim chief executive officer since 1 April, will continue as chairman of the NuVasive board of directors.
TheraCell appoints Gunnar Andersson to board of directors and surgeon advisory...
Andersson is the Ronald L DeWald professor and chairman emeritus of the Department of Orthopedic Surgery at Rush University Medical Center and a surgeon at Midwest Orthopedics at Rush in Chicago, USA.
Medtech receives Australian marketing authorisation for ROSA and signs distribution agreement...
The company signed a distribution contract for Australia and New Zealand with Surgicom, a company specialising in the distribution and marketing of innovative medical devices, particularly in orthopaedics.
CE mark and FDA clearance for Implanet’s new JAZZ diameters
The clearance covers Implanet’s 3.5mm, 4mm, 4.5mm and 6mm JAZZ rods, adding to the original 5.5mm diameter clearance.
First operation with individualised 3D-printed cervical titanium implant completed
The operation was planned and executed by Uwe Spetzger, professor and chairman of the Department of Neurosurgery of the Klinikum Karlsruhe in Germany.
Oral steroids for acute sciatica produce limited improvement in function and...
Among patients with acute sciatica caused by acute radiculopathy, a short course of oral steroids resulted in only modest improvement in function and none in pain, according to a study in the Journal of the American Medical Association.
InVivo Therapeutics reports update of first two spinal cord injury patients...
The Neuro-Spinal Scaffold was implanted in the first patient in October 2014 at the Barrow Neurological Institute, Phoenix, USA, and in the second patient in January 2015 at the Carolinas Medical Center, Charlotte, USA.
EOS imaging launches EOS 3D Service
Montreal-based online modelling service to provide personalised 3D data from EOS Stereo-Radiographic patient images.
New Halyard ON-Q data show reductions in opioid consumption and length...
Decreased length of stay and reduction in narcotic use cited as benefits of treatment with ON-Q in inpatient and outpatient settings.
Top 100 papers in lumbar spine surgery reflect trends in low...
Samuel K Cho and colleagues of Icahn School of Medicine at Mount Sinai, New York City, USA, performed a literature review to analyse and quantify the most important research papers on lumbar spine surgery.
Paradigm Spine announces publication of long-term coflex results
"Therapeutic sustainability and durability of coflex Interlaminar Stabilization after decompression for lumbar spinal stenosis: a four year assessment" was published in the International Journal of Spine Surgery.
INSITE trial receives Leon L Wiltse Award for best paper at...
The award, sponsored by Hansen Yuan and his wife, is voted on by the committee chairs each year and is based on a combination of quality of submitted abstract and podium presentation.
Non-fusion alternatives to traditional fusion in elderly patients
The indications for fusion in elderly patients are often not definitive. Alternatives to fusion have thus emerged including interspinous devices and dynamic stabilisation, writes Scott L Blumenthal.
Bony decompression remains the gold standard for treating lumbar spinal stenosis
The use of surgical interspinous implants has been a controversial subject. Wouter A Moojen writes that the efficacy of such devices should be challenged in order to adhere to medical ethical standards and protect patients.
Medtech announces the sale of three ROSA surgical robots in Asia
Two of the three ROSA systems were sold in China, a key driver in Asia and one of Medtech's target markets for growth, while the third was sold in India.
The potential of augmented vertebroplasty in treating extreme vertebral fractures
Alexis Kelekis and Dimitrios Filippiadis write that augmented vertebroplasty could offer improved mechanical and structural support compared with standard vertebroplasty in the treatment of extreme vertebral fractures.
Patient-reported three-month spine surgery outcomes do not reliably predict results at...
Matthew J McGirt presented research on patient-reported outcomes at three-months during the 2015 American Association of Neurological Surgeons Annual Scientific Meeting.
Vancomycin powder may protect against surgical site infection, though the most...
The data came from a meta-analysis presented by Nickalus R Khan, at 2015 American Association of Neurological Surgeons Annual Scientific Meeting.
Ellipse Technologies’ external remote controller for MAGEC system receives FDA clearance
The company says that the ERC 2 provides improved ergonomic handling and greatly enhanced user interfaces over the first generation ERC.
Nexxt Spine announces full market release of Struxxure anterior cervical plating...
Struxxure is an ultra-low profile anterior cervical plate with a design rationale to help minimise the risk of adjacent-level ossification.
Medtronic announces launch of Divergence standalone interbody cage
The device is now commercially available for the treatment of anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
Integra LifeSciences appoints new SeaSpine chief executive officer and chief financial...
SeaSpine Holdings Corporation will be an independent, publicly traded company following the completion of its spin-off from Integra.
Medicrea announces US launch of LigaPASS band system for spinal posterior...
The latest generation system includes improved surgical capabilities and expanded Food and Drug Administration indications.
Medtronic receives FDA clearance for Zevo anterior cervical plate system
This system is now commercially available for the treatment of cervical degenerative disc disease, trauma, tumours, deformity, pseudoarthrosis, and/or failed previous fusions.
First US and international surgical implantations of ZIP 51 interspinous implant...
The US surgery was performed at NEA Baptist Memorial Hospital in Jonesboro by Rebecca Barrett-Tuck and the international surgery was performed at the Protestant Hospital in Göttingen, Germany by Christian Reparon.
Mazor Robotics’ guidance system completes 10,000th procedure
The Renaissance Guidance System was launched in mid-2012 and is being used by orthopaedic and neurosurgeons to perform a range of spine and brain surgeries.
EOS imaging announces first installation in Hong Kong
The Department of Orthopaedics and Traumatology at the Chinese University of Hong Kong (CUHK) has become the first hospital in Hong Kong to install the EOS system.
Brainlab Introduces new generation of volumetric arc therapy at ESTRO
Brainlab has introduced new automated stereotactic radiosurgery planning tools at ESTRO 2015 which enable improvised generation of consistent treatment plans for volumetric arc therapy delivery.
Diagnosing chronic pain using evidence-based medicine will improve outcomes and reduce...
Low back injuries are the most costly musculoskeletal condition in US workers’ compensation claims, representing 20-25% of all costs.
Meditech Spine uses Invibio PEEK-OPTIMA HA Enhanced for new cervical intervertebral...
Meditech Spine’s cervical intervertebral fusion devices "the Talos line "rely on the novel implantable polymer from Invibio Biomaterial Solutions, PEEK-OPTIMA HA Enhanced.
Safe Orthopaedics announces European launch of its range of fenestrated screws...
Having recently been granted CE mark, Safe Orthopaedics' fenestrated screw has lateral windows enabling cement to be injected into osteoporotic vertebra in order to strengthen the screw's anchoring to the bone.
Implanet announces clinical results for JAZZ Band use in idiopathic scoliosis...
This study represents the final phase of the JAZZ Band's clinical validation and highlights its safety and efficiency in the treatment of idiopathic scoliosis.
Data demonstrate reduced subsidence of Endoskeleton titanium interbody fusion implants compared...
The study compared the subsidence rate and overall subsidence amount of Titan Spine's Endoskeleton TA device with a commercially-available PEEK device at the annual meeting of ISASS.
New software helps improve surgical safety
Results from its first clinical evaluation show that the LevelCheck software achieves 100% accuracy in 26 seconds.
Zimmer announces extension of outside date for pending Biomet merger
The outside date for completing the proposed merger has been extended from 24 April to 23 July, 2015.
NASS launches new features for SpineConnect
NASS members and attendees of NASS meetings can now post cases and images, share knowledge and ask questions of thousands of spine experts from around the world.
Mazor Robotics reports orders for three Renaissance systems in Q1 2015
In the USA, the Renaissance system was purchased by Arrowhead Hospital, located in Glendale. Internationally, the systems were installed at hospitals in Germany and Taiwan.
OfferBoard Securities announces Series B financing for Atlas Spine solutions
Atlas Spine has announced a plan to raise US$5m through OfferBoard Securities to further its existing business and monetise its patented portfolio of spinal implant product systems.
Physical therapy and surgery produce the same results for stenosis in...
Lumbar spinal stenosis symptoms were relieved and function improved in as many patients utilising physical therapy as those undergoing surgical treatment, University of Pittsburgh researchers have shown in a new study.
Data suggesting that PEEK produces an inflammatory environment favouring cell death...
Specifically, the data, published in Spine, show that fibrous tissue formation around PEEK implants "may be due to the creation of an inflammatory environment."
Microdecompression is equivalent to open laminectomy for central stenosis of the...
A new study was undertaken to examine the case for minimally invasive microdecompression as the authors believed that the general surgical trend towards minimally invasive procedures has not been backed by solid evidence.
Heidi Prather was appointed President of the North American Spine Society (NASS) at its most recent Annual Meeting in November 2014. She spoke to Spinal News International about her career to date and the goals of her presidential term.
Minimally invasive surgery with perioperative non-opioid analgesics could be “a game...
Michael Wang has pioneered the awake minimally invasive TLIF using the liposomal bupivacaine Exparel. He spoke to Spinal News International about why the combination of Exparel and minimally invasive methods could change the nature of spinal surgery.
Excessive mobile technology use is damaging the cervical spine
Kenneth K Hansraj wrote for Spinal News International following the publication of his study, "Assessment of stresses in the cervical spine caused by posture and position of the head", which made waves worldwide.
Myelopathy is associated with increased all-cause morbidity and mortality following ACDF
The authors of a new study used the American College of Surgeons National Surgical Quality Improvement Program database to identify 5,256 ACDFs carried out from 2010-2012, of which 1,425 were performed for cervical myelopathy.
Phone counselling reduces pain and disability after spinal surgery
Research at Johns Hopkins University, Baltimore, USA, suggests that a short series of phone conversations with trained counsellors can substantially boost recovery and reduce pain in patients after spinal surgery.
NuVasive chief executive officer resigns following board investigation
An independent investigation overseen by the NuVasive board found that Alex Lukianov had not complied with company expense reimbursement and personnel policies.
Paracetamol is ineffective in the treatment of low back pain
Researchers reviewed the results of 13 randomised trials comparing the efficacy and safety of paracetamol with placebo for spinal pain (neck or low back pain).
Daiichi Sankyo Inc and Asubio Pharmaceuticals merge
Asubio Pharmaceuticals’ parent company, Asubio Pharma Co, which is based in Japan, will continue to operate as a wholly owned subsidiary of Daiichi Sankyo Co, with a focus on discovery research.
A quarter of opioids prescribed for chronic pain are being misused...
New estimates suggest that 20-30% of opioid analgesic drugs prescribed for chronic pain are misused, while the rate of opioid addiction is approximately 10%, reports a study in PAIN journal.
PCM replacement disk surgery offers superior outcomes to ACDF
The PCM cervical disk has been suggested as a motion-preserving alternative to an anterior cervical discectomy and fusion procedure, which in fusing the affected portion of the spine reduces motion.
European Commission clears Zimmer’s pending Biomet merger
The transaction remains subject to clearance by the US Federal Trade Commission, as well as other customary closing conditions. Zimmer expects the deal to be completed in April 2015.
Benvenue Medical signs group purchasing agreement With Novation for the Kiva...
The Kiva system was selected through the Novation Innovative Technology programme, which is designed to ensure that members have access to innovative health care technology.
Varian Medical spotlights New Edge radiosurgery suite for non-invasive surgical procedures
The Edge radiosurgery suite is a technology system for rapidly delivering precise, non-invasive surgical procedures in the treatment of cancer of the areas that are typically difficult to treat surgically, such as the brain and spine.
InVivo reopens enrolment for subjects for anticipated completion of ongoing pilot...
Barring significant safety issues, the final three subjects of this pilot trial will be enrolled concurrently and without mandatory safety hold between enrolment of each subject.
First patient implant of Arena-C HA Enhanced cervical intervertebral body fusion...
The Arena-C HA with PEEK-OPTIMA HA Enhanced, manufactured by SpineFrontier, is a spinal implant device that is produced with a "revolutionary" new biomaterial to enhance spinal fusion technology.
Zimmer debuts new modular external fixation system
Available in both small (6mm) and large (11mm) systems, the XtraFix external fixation system from Zimmer is a modular system that offers surgeons advances in design technology and materials.
K2M announces 510(k) clearance of the Nile alternative fixation spinal system
Nile features low-profile implants and ergonomic instruments intended to provide stabilisation between the spine and the rod, allowing for reduction, translation, compression and distraction while sparing the anatomy.
Stryker Spine receives FDA clearance for new lumbar plating system
The LITe plate system will be featured at booth #443 during the American Academy of Orthopaedic Surgeons Annual Meeting (24-28 March, Las Vegas, USA).
DePuy Synthes expands adult deformity offering with four new products
The company introduced the Expedium osteotomy system for spinal reconstruction, Viper cortical fix X-Tabs for fixation in percutaneous surgery, Vivigen cellular bone matrix and enhancements to the Synapse system.
Stryker to launch BIO4 at the American Academy of Orthopaedic Surgeons...
BIO4 possesses all four characteristics involved in bone repair and regeneration: osteoconductive, osteoinductive, osteogenic and angiogenic.
Implanet announces publication of a cost effectiveness study of the Jazz...
The study found approximately US$11,700 of incremental profit per adolescent idiopathic scoliosis procedure using a Jazz hybrid construct.
X-spine launches anterior lumbar standalone fusion system
Irix-A combines a polymer body with an integrated titanium ring for added strength and durability, a titanium plasma coating of bone-apposing surfaces and a locking mechanism for screw fixation.
Japan Fair Trade Commission clears pending Zimmer-Biomet merger
Under the terms of the merger agreement announced on April 24, 2014, Zimmer will acquire Biomet in a cash and stock transaction valued at approximately US$13.35bn, including the assumption of net debt.
Stryker Spine launching new anterior cervical plating system
Stryker is launching Tempus, its new anterior cervical plating system during the American Academy of Orthopaedic Surgeons Annual Meeting (24-28 March, Las Vegas, USA).
Spinal surgery diminishes low back pain and improves sexual function
Research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons found that 70% of chronic low back pain patients consider sexual activity relevant to their life quality.
Acrylic cages are good alternatives to bone graft and PEEK in...
In a new study, an acrylic cage produced improved fusion rates and disk space height compared with a PEEK cage, and was also significantly cheaper.
Intellirod Spine announces licensing milestone in development of spinal sensor
Intellirod Spine has entered into licensing and distribution agreements with X-spine Systems to utilise X-spine Fortex implants in conjunction with Intellirod’s forthcoming Loadpro disposable microelectronic sensor.
Patient misconceptions concerning lumbar spondylosis diagnosis and treatment persist
As expectations of treatment can influence clinical outcomes, the authors of a new study write that identification of these misconceptions is critical to providing informed and quality healthcare.
John Dahldorf joins Benvenue Medical as chief financial officer
As chief financial officer at Benvenue Medical, Dahldorf will partner with the senior management team to help shape the company's long-term strategy and ensure capital needs are met.
Physician workforce projections show that the US doctor shortage remains significant
Within the overall projected physician shortage, the study estimates a shortage of 12,000-31,000 primary care physicians, and a shortfall of 28,000-63,000 non-primary care physicians.
joimax receives 510(k) clearance for Percusys pedicle screw-rod system
The Percusys system is a multi-functional implant for use during spinal stabilisation procedures, allowing flexibility to perform surgery through a percutaneous, minimally invasive or open approach.
Simplify cervical artificial disc receives IDE approval
Investigational device exemption trial approval follows recent CE mark approval, with initial EU/Asia Pacific commercialisation to begin this year.
Robotic assistance improves spine tumour surgery accuracy and safety
This study used Mazor Robotics' Renaissance device, which guides the surgeon in the placement of spinal instrumentation according to a preoperatively-planned trajectory.
Complications in minimally invasive transforaminal lumbar interbody fusion remain rare with...
The perioperative complication rate across all 531 patients was reported at 15.6% (n=80), and the incidence of durotomy "the most common complication "was 5.1%
Stimwave announces first full body 3-Tesla MRI conditional neuromodulation medical implantable...
Stimwave's Wireless Pain Relief technology, the Freedom stimulator, means that chronic pain patients are able to have 3-Tesla full body magnetic resonance imaging examinations with the device implanted.
Stem cell transplant shows promise for treatment of degenerative disc disease
Stem cell transplant was viable and effective in halting or reversing degenerative disc disease of the spine, a meta-analysis of animal studies showed, in a development expected to open up research in humans.
Life Spine announces FDA clearance of transition connector implants to thoracolumbar...
The clearance includes domino, in-line, and wedding band rod-to-rod connectors, open and closed offsets, and "U-shaped" connectors.
Superion interspinous process spacer found to be as effective and less...
The FDA investigational device exemption study, published by The Spine Journal, involved 391 randomised patients at 29 sites in the USA between August 2008 and December 2011.
EOS imaging announces first Belgian installation
A second EOS system will be installed later in 2015 in the University Hospitals Gasthuisberg campus, making the Leuven network the second European hospital network to acquire multiple EOS imaging systems.
First Glyder facet restoration surgery completed in Cyprus
The device was implanted to address new-onset facet joint pain in a patient with a previous total disc replacement.
SpineGuard and Zavation announce first US co-development partnership for the Smart...
The co-development partnership is for the integration of SpineGuard's Dynamic Surgical Guidance technology into Zavation's pedicle screw system.
SI-Bone reaches 15,000 iFuse procedure milestone
Over 900 surgeons have now performed the iFuse procedure in the USA and 17 countries across Europe.
Adolescent lumbar disk herniation patients are more satisfied with surgical outcomes...
In a new study 86% of adolescents were satisfied with the outcome of surgery compared to 78% in the younger adults and 76% in the older adults group.
Providence Medical Technology granted CE mark for DTRAX line of cervical...
Providence Medical Technology has obtained CE mark for its DTRAX spinal system, DTRAX cervical cage, and DTRAX bone screw.
VertiFlex announces FDA Advisory Panel support for the Superion interspinous spacer
The Superion interspinous spacer system is a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis.
InVivo announces new Neuro-Spinal Scaffold clinical trial site
Froedtert & the Medical College of Wisconsin has been added in the company's ongoing investigational device exemption pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury.
Interbody fusion more cost-effective with better functional outcomes than posterolateral fusion
When second reoperations were included, the cost-effectiveness ratios suggest moderate long-term cost savings and better functional outcomes with the interbody fusion.
Manual-thrust manipulation offers best improvements for acute and subacute low back...
Though manual-thrust manipulation provided greater short-term reductions in disability and pain scores compared with mechanical-assisted manipulation and usual medical care, any significant differences were short-term and lasted no longer than three months.
3D bone printing for the spine
3D bioprinting of a living bone construct can be used for more effective spinal fusion in the treatment of a collapsed vertebra, using areas with bone forming cells and areas for vascularisation.
Direct repair surgery with screw fixation for young lumbar spondylolysis patients...
The study found that although both the intensity and frequency of lower back pain had significantly improved at final follow-up compared with preoperative level, pain frequency tended to worsen after six months.
Medtronic receives expanded indications of the Vertex reconstruction system
The Vertex system is now FDA cleared for lateral mass and pedicle screw fixation in the posterior cervical spine.
Simplify Medical announces CE mark for MRI-compatible cervical artificial disc
The disk has endplates designed to be more compliant with the vertebral bodies under loading common to the cervical spine and includes disc heights as small as 4mm for smaller patient anatomy.
Study supports use of i-FACTOR as alternative to autograft in chronic...
i-FACTOR biologic bone graft features synthetic small peptide (P-15) technology that supports bone growth through cell attachment and osteoblast differentiation.
Minimally invasive electrical muscle stimulation corrects spinal curvature in children
The StimulAIS Project aims to introduce alternative scoliosis treatments based on electrical muscle stimulation of deep paraspinal rotator muscles "a technique known as functional electrical stimulation.
Amedica submits 510(k) application for interbody spacers with porous silicon nitride...
Pursuant to Section 510(k), the FDA has 90 days in which to clear the class II medical device for commercial distribution or to seek additional information.
SpineGuard and Neuro France Implants in co-development partnership for the first...
SpineGuard's Dynamic Surgical Guidance technology will be embedded into Neuro France Implants' pedicle screw system to provide unprecedented accuracy, enhance the surgical work flow, and match health economic trends.
Nanotherapeutics’ NanoFUSE demineralised bone matrix receives expanded 510(K) marketing clearance
Bone void filler product is cleared for use in spinal fusion surgery.
Spinal sealant system provides better intraoperative watertight closure than standard of...
The study used a low-swell PEG hydrogel sealant as an adjunct to sutured dural repair and compared it to standard of care methods of obtaining watertight dural closure in subjects undergoing spinal surgery.
Medtronic agrees US$2.8m False Claims Act settlement
Prosecutors alleged that the company made illegal payments to physicians in 20 US states from 2007-2011 in exchange for recommendations of procedures that were neither safe nor effective.
First spinal fusion patient treated with Luna 360 interbody fusion system
The Luna 360 system is designed to be inserted in a linear, elongated state to minimise tissue retraction and protect the neural structures.
Expanding Orthopedics presents FLXfit at ArgoSpine
Expanding Orthopedics has announced that the FLXfit 3D articulated and lordotic expandable interbody cage was presented at the ArgoSpine Meeting in Paris, France.
First surgical implant of ZIP ULTRA interspinous device performed in Switzerland
The ZIP ULTRA implant consists of the "One-Step" locking mechanism, which eliminates the use of a set screw, articulating spikes and various sizes to accommodate variations in patient anatomy.
ChoiceSpine aquires VEO lateral access and interbody fusion system
The VEO system is designed to treat degenerative disc disease through a minimally invasive lateral approach, and is the first of five new products that ChoiceSpine plans to launch in 2015.
Spinal decompression and fusion to relieve pain from spinal stenosis
Loyola Medicine orthopaedic surgeon Bartosz Wojewnik performs spinal decompression and fusion surgery to bring his patient immediate pain relief.
EOS imaging announces corporate agreement with the Shriners Hospitals for children
Facilitates acquisition process of the EOS system throughout Shriners' network of 22 paediatric hospitals.
Nevro receives expanded MR-conditional labelling for Senza system in Europe and...
Senza is the first implantable spinal cord stimulator system that is 3 Tesla MRI-compatible.
Lumbar discectomy efficacy is diminished with revision surgeries
By the third discectomy patients were reporting falling quality-life adjusted years scores.
The sedimentation sign is associated with spinal stenosis surgical treatment outcomes
The authors carried out their analysis in response to studies have suggested that positive sedimentation sign on magnetic resonance image may be a possible prognostic indicator.
Implanet secures European intellectual protection for its JAZZ technology
The patent applies to the entire JAZZ system and definitively secures full protection of the implant's technical characteristics.
Precision Spine recieves FDA clearance for Reli SP spinous plating system
The company also announced that its Reform pedicle screw system has received expanded indications from the FDA.
Misonix acquires remaining Bonescalpel business from Aesculap
The BoneScalpel is an ultrasonic surgical system used for tissue-selective bone dissection that encourages en bloc bone removal and refined osteotomies while sparing elastic soft tissue.
Amedica given FDA clearance for two-level cervical interbody cage indications
Clearance is based on data showing the company's silicon nitride devices used in multi-level procedures are as safe and effective as other devices used in single level procedures.
SpineGuard receives EU patent for its Smart Screw
SpineGuard's proprietary technology platform, already used in its PediGuard product, enables surgeons to place pedicle screws "more safely and accurately".
DePuy Synthes Spine expands indication for Synapse occipital-cervical-thoracic system
First screw-rod occipital-cervical-thoracic system cleared for the use of screws in the posterior cervical spine.
Spinal cord injury patients exhibit an increased risk of acute myocardial...
The findings may have broad implications for the surveillance of spinal cord injury patients.
BMI is a risk factor for adjacent segment disease in lumbar...
Although adjacent segment disease is an important complication after fusion of degenerative lumbar spines, the role of BMI in adjacent segment disease "has been addressed less".
Cerapedics receives CE mark and TGA listing for i-FACTOR Flex FR...
P-15 bone graft technology now features enhanced handling with addition of purified silk fibres.
Medtronic completes acquisition of Covidien
Under the terms of the acquisition agreement, Medtronic Inc and Covidien plc are now combined under Medtronic plc.
Tranexamic acid reduces surgical bleeding in spine surgery without increased risks
Tranexamic acid is a lysine analogue which inhibits activation of plasminogen and has shown to be beneficial in reducing surgical blood loss.
EOS imaging receives FDA clearance for Micro Dose
Micro Dose option brings paediatric spine follow-up imaging exams equivalent in dose to one week of natural background radiation.
InVivo update of first acute spinal cord injury subject implanted with...
In the time between implantation and the three-month post-injury assessment, there were no reported serious adverse events associated with the Neuro-Spinal Scaffold.
Mainstay Medical applies to start US clinical trial of ReActiv8
ReActiv8 is an implantable neurostimulation device designed to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated.
The Medicines Company receives CHMP positive opinion for Raplixa sealant powder
Raplixa is a ready-to-use, biologically active, powdered fibrin sealant that provides haemostasis in a wide range of bleeding settings.
Titan Spine records significant growth with over 27,000 implanted fusion devices
These figures reflect a significant growth over the past year with the continuing adoption of its spinal interbody fusion devices featuring proprietary surface technology by surgeons.
Aesculap introduces the ProSpace XP lumbar interbody system
The ProSpaceXP is an optimum fusion of the osteoconductive PlasmaporeXP coating and PEEK-Optima core for enhanced implant stability, artifact-free imaging, and an osteoconductive scaffold for PLIF procedures.
Nevro receives FDA approvable letter for Senza spinal cord stimulation system
According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza.
ISO 13485 and CE mark for Dymicron’s Triadyme-C cervical total disc...
These certifications will now allow for the commercialisation of the Orthopedic Diamond cervical disc in the European Union and other countries around the world that recognise the CE mark approval process.
Obese patients have an increased rate of incidental durotomy in lumbar...
the trend of growing rates of obesity in the wider population means that the risks of incidental durotomy will increase as time goes on, as will other obesity-related surgical complications.
Interleukin 4 may assist in developing treatment for central nervous system...
Interleukin 4 helps protect the body's neurons and promote their regeneration, whereas uncontrolled inflammation can destroy them.
The use of photographs can improve patient satisfaction following scoliosis surgery
Patients in the first group were shown the preoperative and most recent follow-up photographs, while patients in the second group underwent routine evaluation but without being shown their photographs.
FDA clears K2M MESA 2 Deformity Spinal System
K2M says that the MESA 2 is the company’s next-generation pedicle screw system designed to address the most complex spinal pathologies.
Spinal Elements set to launch cervical Ti-Bond-coated implants following FDA approval
The use of Ti-Bond results in a porous titanium bone-opposing surface while allowing for direct visualisation of the fusion mass through the radiolucent PEEK material.
Myelopathy linked with increased all-cause morbidity and mortality following ACDF
Led by Adam M Lukasiewicz, Yale School of Medicine, USA, the retrospective cohort study examined a total of 5,256 ACDF patients who underwent surgery from 2010-2012.
First ROSA Spine robot procedure completed in France
Assisted by the ROSA Spine robot, the surgical team implanted four pedicle screws with a minimally invasive technique, whilst reducing radiation exposure for the patient and health care staff in the operating room.
Texas Back Institute performs first US FLXfit 3D expandable interbody cage...
Expanding Orthopedics has announced that the first US surgery with the FLXfit 3D expandable interbody cage, has been successfully performed by John Peloza at the Texas Back Institute in Dallas, USA.
Spinal Simplicity receives FDA clearance for Minuteman
The a pre-packaged sterile supplemental posterior fixation system offers a minimally invasive alternative to pedicle screws and other spinous process plates that are placed in open procedures.
ECA Medical Instruments’ disposable instrument fixation kit gains FDA approval with...
The sterile-packed kit features a full complement of fixation instruments in a single sterile packed tray including proprietary and cannulated torque-limiters, ratchets and fixed drivers.
Updated guidelines for fusion procedures in the lumbar spine
Michael G Kaiser reviews the key differences between the update of the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves guidelines for fusion procedures for degenerative disease of the lumbar spine and the original guidelines.
Lumbar spinal stenosis successfully treated with lumbar spinous process-splitting laminoplasty
The study used a modified version of the LSPSL procedure in which laminoplasty is performed as an alternative to laminectomy.
Interbody spacers with silicon nitride centre provide equivalent fusion to PEEK...
Amedica's CASCADE study enrolled 104 patients in a prospective clinical trial that independently scored fusion rates and clinical outcomes at 12 months follow-up.
FDA clearance and first clinical use of Valorem Surgical’s MaxiMIS spinal...
The MaxiMIS will be in limited market release through the end of Q1 2015 and is planned for full launch in Q2 2015.
Decompression surgery for degenerative lumbar spinal stenosis effective in patients over...
Swiss investigation suggests that lumbar decompression surgery could improve patient satisfaction for those over 80 years of age as much as for younger patients.
Posterior revision decompression and lumbar fusion surgery of the spine
John J Carbone, MedStar Harbor Hospital, Baltimore, USA, performs a posterior revision decompression and lumbar fusion surgery of the spine.
PorOsteon announces FDA clearance of the Phusion Metal cervical cage
The Phusion Metal cervical cage is designed to maximise bone growth through a fully interconnected porous structure and matching the modulus of living cancellous bone.
Benvenue Medical appoints Rick Simmons to lead growth of Luna franchise
Simmons brings more than 30 years of experience in medical devices and a deep knowledge of the spine industry, having held leadership roles at several well-respected companies in the category.
Surgical and nonsurgical spinal stenosis treatment outcomes similar after eight years
While earlier reports suggested an advantage of surgery, the updated analysis finds no significant difference in pain, functioning, and disability at eight years' follow-up.
Paramed presents new MROpen applications
The new clinical applications will utilise MROpen in interventional MRI procedure as well as in hybrid integrated operating rooms to assess the outcome of neurosurgery and spine surgery in real time.
Osiris and Stryker enter strategic partnership to market Osiris’ viable bone...
The agreement provides Stryker with exclusive, worldwide rights to Osiris' viable bone matrix under the name BIO4.
K2M announces completion of first surgery using Capri corpectomy cage system
The Capri system is intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma.
StemCells transplants first participant in phase II clinical trial in cervical...
Pathway study to assess the potential of human neural stem cells to restore motor function
ProCure Proton Therapy Center celebrates the 1,000th patient to complete treatment
The 1,000th patient underwent proton therapy treatment following several unsuccessful surgeries.
First European approval for implant made of PEEK-OPTIMA HA Enhanced
Implants made from the PEEK-OPTIMA HA Enhanced implantable polymer have received their first CE mark approval, granted to implants supplied by the Karmed Saglik Group for the treatment of degenerative spinal conditions.
InVivo announces FDA approval to expedite enrolment for ongoing pilot trial
Under the new plan InVivo will submit two months of safety data on its Neuro-Spinal Scaffold to the FDA for the first subject enrolled in October.
Commonly prescribed painkiller may not be effective in controlling lower back...
A study published in the journal Neurology shows that pregabalin is not effective in controlling the pain associated with lumbar spinal stenosis.
Dorsal root ganglion identified as a promising target for neuromodulation
At the 18th annual NANS congress, researchers presented 20 scientific abstracts highlighting clinical results of the Axium neurostimulator system for the treatment of chronic pain.
Stimwave launches chronic pain trial for neuromodulation device
Stimwave has announced initiation of a clinical study of its wireless high frequency stimulator for the treatment of chronic, non-specific origin low back pain.
Second 3D printed vertebrae implantation procedure successful
A second patient has received 3D implanted vertebrae in a successful procedure at Zhejiang University School of Medicine, China.
SDRI appoints joimax as exclusive distributor for Synergy cervical disc in...
SDRI enters into a five-year agreement with joimax GmbH for exclusive rights to market and distribute the company's Synergy family of products in Germany, Austria and Switzerland.
NASS updates guidelines for diagnosis and treatment of degenerative lumbar spondylolisthesis
The North American Spine Society has published new guidelines to help spine care specialists diagnose and treat degenerative lumbar spondylolisthesis.
Low-dose stereo-radiography can provide reliable global 3D quantitative analysis
Brice Ilharreborde tells Spinal News International that low-dose stereoradiography can now reliably provide a global 3D quantitative analysis of scoliotic deformities in a context of routine clinical use.
Data demonstrate long-term, low back pain relief with Boston Scientific Precision...
New retrospective data evaluating the Precision Spectra spinal cord stimulator system demonstrate sustained and significant relief of low back pain 12 months after implantation.
Titan Spine receives 510(k) clearance for nanoLOCK surface technology
Titan Spine has received 510(k) clearance from the US FDA to market its Endoskeleton line of interbody fusion implants featuring its nanoLOCK surface technology.
Chronic low-back pain research standards announced by NIH task force
The National Health Institute (NIH) Task Force on Research Standards for Chronic Low-Back Pain has published new back-pain research standards.
Aesculap’s S4 Element MIS system wins best new technology award
Aesculap Implant Systems' S4 Element MIS system has been recently named 2014's Best New Technology for Minimally Invasive Spine Care by Orthopedics This Week.
Patient satisfaction following spinal care could be linked to age, education...
A study presented at the annual meeting of the Cervical Spine Research Society suggests that patient satisfaction after spinal care could be linked to patient age, education level and smoking status.
Outpatient anterior cervical discectomy and fusion associated with improved surgical quality
Sheyan Armaghani presented a study at the Cervical Spine Research Society Annual Meeting supporting the safety and efficacy of anterior cervical discectomy and fusion in ambulatory surgery centres.
Barrier-breaking drug may lead to spinal cord injury treatments
Injections of a new drug may partially relieve paralysing spinal cord injuries, based on indications from a study in rats, partly funded by the National Institutes of Health.
Brace treatment for compression fractures may not provide additional improvement in...
A study published in Journal of Bone & Joint Surgery has found that patients who wore a brace as treatment for a spinal compression fracture had comparable outcomes in terms of pain, function and healing when compared to patients who did not wear a brace.
Toxin from tobacco smoke could increase pain in spinal cord injury
A neurotoxin found in tobacco smoke thought to increase pain in people with spinal cord injury has now been shown to accumulate in mice exposed to the equivalent of 12 cigarettes daily over a short time period.
510(k) clearance for Spineart’s ROMEO2 PAD
Spineart's ROMEO2 PAD posterior axial device has received 510(k) clearance from the US Food and Drug Administration.
New clearance for DePuy Synthes paediatric device to treat thoracic insufficiency...
DePuy Synthes Spine has received 510(k) clearance from the US FDA to market the VEPTR/VEPTR II vertical expandable prosthetic titanium rib devices for the treatment of thoracic insufficiency syndrome.
FDA clears Stimwave’s injectable wireless pain relief system
Stimwave has received FDA clearance to market its wireless microtechnology neuromodulation device for relief of chronic back and leg pain.
Spinal Modulation completes enrolment of Axium neurostimulator US pivotal trial
Spinal Modulation has completed enrolment of the ACCURATE study, a randomised, controlled pivotal clinical trial designed to evaluate the safety and efficacy of the company's Axium neurostimulator system.
Novel BoneScalpel technique published in Operative Neurosurgery
Misonix has announced a new clinical publication entitled: "Ultrasonic total uncinectomy: A novel technique for complete anterior decompression of cervical nerve roots," by Peyman Pakzaban, Houston, USA.
St Mary’s Medical Center offers robotic guidance system for spine surgery
Dignity Health St Mary's Medical Center, San Francisco, USA, has added the Mazor Robotics Renaissance computer-generated guidance system to its multidisciplinary spine centre.
SpineGuard passes ANVISA inspection
SpineGuard has received certification from the Brazilian governmental regulatory authority ANVISA following a three-day inspection in Paris.
GE Healthcare unveils SIGNA Pioneer’s MAGiC
GE Healthcare has unveiled SIGNA Pioneer, a new 510(k)-pending 3.0T magnetic resonance imaging (MRI) system, at the Radiological Society of North America annual meeting in Chicago, USA (30 November - 5 December).
Obesity does not affect the success and outcomes of degenerative scoliosis...
A new study published in the journal Spine has suggested that patient obesity has no impact on the correction, comorbidities, or complication rates associated with degenerative scoliosis correction surgery.
Interventional Spine receives FDA clearance Lateral Opticage expandable interbody
Interventional Spine has announced US Food and Drug Administration (FDA) clearance of its Lateral Opticage expandable intervertebral body fusion device.
Centinel Spine introduces Midline II Lumbar Integrated Interbody system
Centinel Spine has introduced Midline II, its next generation STALIF family Lumbar Integrated Interbody fusion device.
Medacta completes first US surgeries with MySpine patient-matched technology
Medacta USA has completed the first successful surgeries in the USA utilising MySpine patient-matched technology using the company's 3D-reconstruction and 3D-printing technologies to produce customised patient-specific surgical guides.
Spineology receives patent allowance for percutaneous spinal fusion approach
The US Patent and Trademark Office has issued a Notice of Allowance for Spineology's "System and method for performing percutaneous spinal interbody fusion."
Use of crosslinks in clinical practice may be avoidable
Crosslinks are routinely used as adjuvants in spinal surgery. Although numerous biomechanical studies are available in the literature, there has been no clinical study that has evaluated the need for crosslinks in clinical situations.
Zyga Technology announces first Glyder device implantation and clinical study data
Zyga Technology has completed the first Glyder Facet Restoration Device commercial surgery and has published 12-month primary outcome data from the GLISSADE study.
Smartphone and tablet usage can cause spinal damage
A study published in Surgical Technology International warns that using smartphones and tablets can lead to spinal damage.
MRI alone may not be enough to accurately diagnose degenerative spondylolisthesis
A magnetic resonance image (MRI) alone may not be enough to accurately diagnose the existence or extent of degenerative spondylolisthesis, a common and often painful spine condition.
Nonoperative treatment of adult spinal deformity does not improve disease state...
A study presented at the 29th annual meeting of the North American Spine Society (NASS) suggests that operative treatment for adult spinal deformity (ASD) improves both disease state and physical function regardless of patient age and deformity type, while nonoperative treatment has no such impact.
EUROSPINE 2014: Interview with Haluk Berk
Haluk Berk, incoming president of EUROSPINE talks about his strategy for the future of the society over the next year.
DePuy Synthes launches ViviGen cellular bone matrix
DePuy Synthes, in collaboration with LifeNet Health, has announced the introduction of ViviGen cellular bone matrix, a differentiated cellular allograft for the repair or reconstruction of musculoskeletal defects.
Heidi Prather named president of North American Spine Society
During the 29th Annual Meeting of the North American Spine Society (NASS), Heidi Prather was named NASS President for 2014-15.
Thompson MIS cleared for Solvay Zeniva PEEK spinal implants
Thompson MIS has received 510(k) clearance from the FDA for its MIS TLIF spacer made of Zeniva polyetheretherketone (PEEK) resin from Solvay Specialty Polymers.
Titan Spine receives FDA approval for nanoLOCK surface technology
Titan Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Endoskeleton line of interbody fusion implants featuring its next-generation nanoLOCK surface technology.