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).
The posterior lumbar cage is intended for use in patients with degenerative disc disease, grade I spondylolisthesis and degenerative scoliosis.
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 has received US Food and Drug Administration clearance for BioTy, a modified surface treatment for use on their headless cannulated trauma screw 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.
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.
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.
Under the exclusive agreement, Stryker's sales team in the UK will promote EOS imaging's products to its existing and prospective customers.
Bioventus has introduced several new products at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons.
Data from a Titan Spine biomechanical study demonstrating that titanium coated polyetheretherketone implants generate particulate debris during impactionhave been published in The Spine Journal.
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 programs can help reduce severe pain and increase function for older adults with chronic low back pain, according to new research.
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.
New research has estimated that the median number of at-home recovery days following spinal fusion for adolescent idiopathic scoliosis is 42.
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.
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.
Two studies have found that osteopathic manipulative treatment reduced pain and improved function in patients suffering from chronic, nonspecific low back pain.
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.
The Xia cortical trajectory implants and instruments are designed for use in less invasive LITe LIF posterior lumbar interbody fusion procedures.
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.
This marks the third EOSapp software planning option offered by the company, following its hipEOS and kneeEOS products.
The patent relates to the anatomical prosthesis design, which is capable of resisting the high forces exerted while the patient is moving.
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 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'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 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.
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.
A series of orthopaedic and spinal procedures have been completed using the Vital 5 ReLeaf catheter in Logan, and Chicago, USA.
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.
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.
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.
The team developed BendGuide, an opto-electronic drilling system that monitors and detects minute changes in guide-wire trajectory during surgery.
A study has shown that pulsed electromagnetic field therapy may reduce cellular inflammation and degradation associated with disc degeneration in human intervertebral disc cells.
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 has enrolled a sixth patient into its INSPIRE study at the Barnes-Jewish Hospital at Washington University Medical Center, St. Louis, USA.
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.
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.
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.
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.
This network includes more than 167 hospitals and 112 standalone surgery centres in the USA, held under the HealthTrust purchasing group.
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.
Whilst smoking has previously been connected with lumbar degeneration, this study has associated it with degeneration of the cervical spine.
Research has associated earlier rehabilitation with modest improvements in functioning and physical independence for patients suffering from spinal cord injuries.
This status categorises EOS as a unique modality, giving it a new reimbursement code with higher coverage than conventional X-rays.
Teutsch joins DSM from Stryker, where he was vice president and general manager of the Orthobiologics Division.
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 is to extend its collaboration with Kasios. The companies aim to combine Bone Therapeutics' Allob cells with Kasios' spinal fusion cage.
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.
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.
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.
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.
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 Group has partnered with BioTiss, in order to consolidate human musculoskeletal tissue processing at their facilities in Austria.
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.
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.
Groppa will oversee the company's marketing activities, and will continue to oversee its US insurance reimbursement strategy.
Spinal joint replacement patients could potentially receive individualised, metal 3D-printed implants, thanks to research partnership Metalysis and TWI.
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.
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.
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.
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.
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.
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.
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".
The AccelSPINE brand will remain intact until the integration is complete, and all relevant regulatory measures have been met.
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.
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 is to launch a new, redesigned version of its website, which will feature the company's newly-released next-generation expandable lumbar cage 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 "alone or in combination with exercise "may reduce the risk of low back pain, suggests a review article published by JAMA Internal Medicine.
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.
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.
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 (MCE) has been developed with the aim of restoring the coordination, control and capacity of the trunk muscles that support the spine.
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.
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.
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.
This case "performed in the USA "follows the product's recent US Food and Drug Administration 510(k) and CE mark clearance.
Vexim has reached the key milestone of 25,000 SpineJack units sold since the market launch of the implant in 2011.
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 has been granted 510(k) clearance from the US Food and Drug Administration (FDA) to market the Rosa spine unit in the USA.
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.
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.
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 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.
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."
This coverage, which should give 2.8 million beneficiaries access to this surgery, will become effective on the 1st February 2016.
Opioid prescribing guidance can have an immediate and long-lasting impact on opioid prescribing rates for minor conditions in an acute care setting.
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.
This new device is designed to combine the functionality of two other ChoiceSpine products; Stealth and Falcon. It also uses PEEK-Optima HA Enhanced.
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.
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.
This system is designed to allow for extreme bone screw angulation and large graft windows. It is due for release in 2016.
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.
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.
This system combines the companies' surgical navigation and minimally invasive endoscopic spine surgery offerings.
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.
The system was purchased by UConn Health, located in Farmington, USA and installed at its John Dempsey Hospital.
This brings the total current US installations of the imaging system to 47, with 7 further platforms shipped for installation.
The new indications approve Infuse for use with certain spine implants made with polyetheretherketone (PEEK).
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.
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.
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.
Additional data from 13 subjects has been released by Mainstay Medical, showing significant and lasting improvements in pain, disability and quality of life.
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.
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.
A study has shown that the procedure can offer an earlier return to work and fewer reoperations treatment by ACDF.
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.
The BioStructures product portfolio includes synthetic, allograft, collagen, and demineralised bone matrix options for surgeons.
The Proclaim Elite SCS system is an upgradeable, non-rechargeable, burst-enabled MR-conditional SCS system.
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.
This decision makes the drug the first new treatment advance for ankylosing spondylitis in 16 years.
Leader Biomedical group supplies a number of bone graft substitutes processed with its eCOO technology, including the eTiss demineralised bone matrix.
The findings, which will be published online in Scientific Reports resulted in significant improvements in the motor and urinary functions of animals.
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.
This research from the Johns Hopkins Children's Center shows children with cerebral palsy, spina bifida, and muscular dystrophy, are most at risk.
This system is designed to reduce the number of surgical steps required during an anterior cervical discectomy and fusion procedure.
A study from the University of Florida has shown that higher dosage is required to achieve relief in older patients.
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.
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 the conference in Las Vegas, USA.
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.
The indication includes improved pain, patient function and quality of life at 12 months.
The procedure was also shown at the SMISS conference for the first time on a cadaver.
The expandable interbody fusion device has received clearance for spinal fusion.
The platform will be available to more than 1,000 patients per year undergoing spine surgeries in Japan.
These proposed payments represent an increase of 14% for outpatient payment and 25% for physician reimbursement, and will become effective on January 1, 2016.
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.
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 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.
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.
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.
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).
Surgeons who attended Misonix's presentations at the conference received hands-on training through peer-to-peer demonstrations of the new platform.
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.
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.
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.
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 Corporation's Interventional Spine business has been granted FDA clearance to market its VertaPlex HV for the treatment of sacral insufficiency fractures.
Life Spine has revealed four new products at the 2015 North American Spine Society meeting in Chicago.
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 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.
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.
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 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
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.
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).
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 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.
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.
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.
The X-Core Mini cervical corpectomy system is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure.
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.
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 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.
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' custom disposable instrument kit was used to successfully secure the first Revolution spine system lumbar implant from Intelligent Implant Systems (ISS).
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.
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.
The first patient surgical implantation of the Alphatec Neocore osteoconductive matrix "a synthetic scaffold for the regeneration of bone "has been successfully completed.
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 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.
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.
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 has released its new line of TRI-GEAR silicone handle ratcheting instruments for use in spine surgeries.
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.
Eight international EOS centres will undertake a multicentre study to evaluate the technology as a predictive tool.
SpineMask Tracker is a non-invasive patient tracker enabling minimally invasive approaches for spine surgery without an additional incision for navigation tracking.
Jazz may be used with other posterior thoracolumbar fixation systems (screws, rods, hooks) available on the market.
Medtech has announced a new sale of its Rosa robot to Frankfurt University Hospital in Germany.
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.
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.
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.
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).
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.
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.
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.
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.
Company to present technical exhibit and host workshop focused on achieving more precise spinal column alignment.
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.
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.
As well as its new financing, the company has also announced the appointment of Jason Hoffman as vice president of global sales.
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.
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.
The new technique reduces complication rates for complex cases where patients are most at risk of infections.
Data from preclinical and human clinical studies has suggested that Remedy Pharmaceuticals' drug candidate, Cirara, inhibits spinal cord oedema and micro haemorrhage formation.
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.
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.
The new procedural option allows surgeons to perform sacroiliac joint fusion through a single incision.
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.
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 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.
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.
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.
Under the terms of the settlement agreement, the company will pay US$13.5m, plus fees and accrued interest.
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.
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.
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.
The difference between genders aids in childbearing, but likely imparts a greater susceptibility for scoliosis and osteoporosis in females.
Centinel Spine has implanted its first two Stalif Midline II-Ti devices at Texas Health Plano, Plano and Florida Hospital Carrollwood, Tampa, USA.
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.
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.
Extended opioid therapy following lumbar fusion surgery for US workers' compensation patients is associated with worse outcomes, a new study has found.
A retrospective clinical study indicates that Safe Orthopaedics' Sterispine system results in reduced postoperative infection, morbidity and mortality.
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.
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.
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 has completed the installation of an EOS imaging system at National Scoliosis Center, a Virginia-based scoliosis treatment clinic.
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.
A study published by the Journal of Spinal Disorders and Techniques may provide a relatively simple method of reducing postoperative spinal surgery infections.
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 has received 510(K) clearance from the US Food and Drug Administration (FDA) to market its enhanced TowerLOX minimally invasive pedicle screw system.
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 has announced the launch of the LITe (Less Invasive Technologies) anterior lumbar interbody fusion (ALIF) Procedural Solution.
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.
Accuro provides untethered ultrasound imaging to automatically guide spinal anaesthesia with additional indications for ultrasound imaging of abdominal, musculoskeletal, cardiac, and peripheral vascular anatomies.
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%.
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.
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.
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.
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.
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 has announced the first use of its new Auto-Adjust pedicle screw in surgical procedures to repair thoracic and lumbar spine fractures.
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.
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.
Platform includes full US release of new Fortress pedicular fixation system and Medius midline retractor system.
Time between injury to arrival at an acute care centre was roughly twice as long for older patients than younger patients.
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.
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.
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.
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.
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.
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.
The first Rosa Spine robot was purchased by Amiens University Hospital in Amiens, France, a centre for the treatment of brain and spine disorders.
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.
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.
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.
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's FortiBridge cervical plates are designed to complement the Nanovis' FortiCore cervical interbody implant system.
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.
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 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.
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 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 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.
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.
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 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.
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.
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'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.
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.
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.
The phase II study is designed to assess the potential of human neural stem cells to restore motor function.
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.
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.
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.
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.
The BoneScalpel is an ultrasonic bone-cutting instrument that provides surgeons a clean, controlled bone incision and removal that is also soft-tissue sparing.
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.
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.
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.
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.
Pain Physician journal publishes results showing lower risk for adjacent-level spine fractures and fewer reoperations with Kiva system.
Lucier, who has been serving as interim chief executive officer since 1 April, will continue as chairman of the NuVasive board of directors.
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.
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.
The clearance covers Implanet’s 3.5mm, 4mm, 4.5mm and 6mm JAZZ rods, adding to the original 5.5mm diameter clearance.
The operation was planned and executed by Uwe Spetzger, professor and chairman of the Department of Neurosurgery of the Klinikum Karlsruhe in Germany.
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.
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.
Montreal-based online modelling service to provide personalised 3D data from EOS Stereo-Radiographic patient images.
Decreased length of stay and reduction in narcotic use cited as benefits of treatment with ON-Q in inpatient and outpatient settings.
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.
"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.
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.
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.
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.
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.
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.
Matthew J McGirt presented research on patient-reported outcomes at three-months during the 2015 American Association of Neurological Surgeons Annual Scientific Meeting.
The data came from a meta-analysis presented by Nickalus R Khan, at 2015 American Association of Neurological Surgeons Annual Scientific Meeting.
The company says that the ERC 2 provides improved ergonomic handling and greatly enhanced user interfaces over the first generation ERC.
Struxxure is an ultra-low profile anterior cervical plate with a design rationale to help minimise the risk of adjacent-level ossification.
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.
SeaSpine Holdings Corporation will be an independent, publicly traded company following the completion of its spin-off from Integra.
The latest generation system includes improved surgical capabilities and expanded Food and Drug Administration indications.
This system is now commercially available for the treatment of cervical degenerative disc disease, trauma, tumours, deformity, pseudoarthrosis, and/or failed previous fusions.
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.
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.
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 has introduced new automated stereotactic radiosurgery planning tools at ESTRO 2015 which enable improvised generation of consistent treatment plans for volumetric arc therapy delivery.
Low back injuries are the most costly musculoskeletal condition in US workers’ compensation claims, representing 20-25% of all costs.
Meditech Spine’s cervical intervertebral fusion devices "the Talos line "rely on the novel implantable polymer from Invibio Biomaterial Solutions, PEEK-OPTIMA HA Enhanced.
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.
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.
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.
Results from its first clinical evaluation show that the LevelCheck software achieves 100% accuracy in 26 seconds.
The outside date for completing the proposed merger has been extended from 24 April to 23 July, 2015.
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.
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.
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.
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.
Specifically, the data, published in Spine, show that fibrous tissue formation around PEEK implants "may be due to the creation of an inflammatory environment."
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.
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.
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.
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.
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.
An independent investigation overseen by the NuVasive board found that Alex Lukianov had not complied with company expense reimbursement and personnel policies.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
BIO4 possesses all four characteristics involved in bone repair and regeneration: osteoconductive, osteoinductive, osteogenic and angiogenic.
The study found approximately US$11,700 of incremental profit per adolescent idiopathic scoliosis procedure using a Jazz hybrid construct.
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.
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 is launching Tempus, its new anterior cervical plating system during the American Academy of Orthopaedic Surgeons Annual Meeting (24-28 March, Las Vegas, USA).
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.
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 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.
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.
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.
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.
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.
Investigational device exemption trial approval follows recent CE mark approval, with initial EU/Asia Pacific commercialisation to begin this year.
This study used Mazor Robotics' Renaissance device, which guides the surgeon in the placement of spinal instrumentation according to a preoperatively-planned trajectory.
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'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 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.
The clearance includes domino, in-line, and wedding band rod-to-rod connectors, open and closed offsets, and "U-shaped" connectors.
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.
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.
The device was implanted to address new-onset facet joint pain in a patient with a previous total disc replacement.
The co-development partnership is for the integration of SpineGuard's Dynamic Surgical Guidance technology into Zavation's pedicle screw system.
Over 900 surgeons have now performed the iFuse procedure in the USA and 17 countries across Europe.
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 has obtained CE mark for its DTRAX spinal system, DTRAX cervical cage, and DTRAX bone screw.
The Superion interspinous spacer system is a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis.
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.
When second reoperations were included, the cost-effectiveness ratios suggest moderate long-term cost savings and better functional outcomes with the interbody fusion.
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 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.
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.
The Vertex system is now FDA cleared for lateral mass and pedicle screw fixation in the posterior cervical spine.
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.
i-FACTOR biologic bone graft features synthetic small peptide (P-15) technology that supports bone growth through cell attachment and osteoblast differentiation.
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.
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'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.
Bone void filler product is cleared for use in spinal fusion surgery.
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.
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.
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 has announced that the FLXfit 3D articulated and lordotic expandable interbody cage was presented at the ArgoSpine Meeting in Paris, France.
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.
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.
Loyola Medicine orthopaedic surgeon Bartosz Wojewnik performs spinal decompression and fusion surgery to bring his patient immediate pain relief.
Facilitates acquisition process of the EOS system throughout Shriners' network of 22 paediatric hospitals.
Senza is the first implantable spinal cord stimulator system that is 3 Tesla MRI-compatible.
By the third discectomy patients were reporting falling quality-life adjusted years scores.
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.
The patent applies to the entire JAZZ system and definitively secures full protection of the implant's technical characteristics.
The company also announced that its Reform pedicle screw system has received expanded indications from the FDA.
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.
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's proprietary technology platform, already used in its PediGuard product, enables surgeons to place pedicle screws "more safely and accurately".
First screw-rod occipital-cervical-thoracic system cleared for the use of screws in the posterior cervical spine.
The findings may have broad implications for the surveillance of spinal cord injury patients.
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".
P-15 bone graft technology now features enhanced handling with addition of purified silk fibres.
Under the terms of the acquisition agreement, Medtronic Inc and Covidien plc are now combined under Medtronic plc.
Tranexamic acid is a lysine analogue which inhibits activation of plasminogen and has shown to be beneficial in reducing surgical blood loss.
Micro Dose option brings paediatric spine follow-up imaging exams equivalent in dose to one week of natural background radiation.
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.
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.
Raplixa is a ready-to-use, biologically active, powdered fibrin sealant that provides haemostasis in a wide range of bleeding settings.
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.
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.
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.
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.
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 helps protect the body's neurons and promote their regeneration, whereas uncontrolled inflammation can destroy them.
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.
K2M says that the MESA 2 is the company’s next-generation pedicle screw system designed to address the most complex spinal pathologies.
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.
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.
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.
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.
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.
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.
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.
The study used a modified version of the LSPSL procedure in which laminoplasty is performed as an alternative to laminectomy.
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.
The MaxiMIS will be in limited market release through the end of Q1 2015 and is planned for full launch in Q2 2015.
Swiss investigation suggests that lumbar decompression surgery could improve patient satisfaction for those over 80 years of age as much as for younger patients.
John J Carbone, MedStar Harbor Hospital, Baltimore, USA, performs a posterior revision decompression and lumbar fusion surgery of the spine.
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.
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.
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.
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.
The agreement provides Stryker with exclusive, worldwide rights to Osiris' viable bone matrix under the name BIO4.
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.
Pathway study to assess the potential of human neural stem cells to restore motor function
The 1,000th patient underwent proton therapy treatment following several unsuccessful surgeries.
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.
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.
A study published in the journal Neurology shows that pregabalin is not effective in controlling the pain associated with lumbar spinal stenosis.
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 has announced initiation of a clinical study of its wireless high frequency stimulator for the treatment of chronic, non-specific origin low back pain.
A second patient has received 3D implanted vertebrae in a successful procedure at Zhejiang University School of Medicine, China.
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.
The North American Spine Society has published new guidelines to help spine care specialists diagnose and treat degenerative lumbar spondylolisthesis.
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.
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 has received 510(k) clearance from the US FDA to market its Endoskeleton line of interbody fusion implants featuring its nanoLOCK surface technology.
The National Health Institute (NIH) Task Force on Research Standards for Chronic Low-Back Pain has published new back-pain research standards.
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.
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.
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.
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.
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.
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.
Spineart's ROMEO2 PAD posterior axial device has received 510(k) clearance from the US Food and Drug Administration.
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.
Stimwave has received FDA clearance to market its wireless microtechnology neuromodulation device for relief of chronic back and leg pain.
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.
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.
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 has received certification from the Brazilian governmental regulatory authority ANVISA following a three-day inspection in Paris.
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).
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 has announced US Food and Drug Administration (FDA) clearance of its Lateral Opticage expandable intervertebral body fusion device.
Centinel Spine has introduced Midline II, its next generation STALIF family Lumbar Integrated Interbody fusion device.
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.
The US Patent and Trademark Office has issued a Notice of Allowance for Spineology's "System and method for performing percutaneous spinal interbody fusion."
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 has completed the first Glyder Facet Restoration Device commercial surgery and has published 12-month primary outcome data from the GLISSADE study.
A study published in Surgical Technology International warns that using smartphones and tablets can lead to spinal damage.
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.
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.
Haluk Berk, incoming president of EUROSPINE talks about his strategy for the future of the society over the next year.
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.
During the 29th Annual Meeting of the North American Spine Society (NASS), Heidi Prather was named NASS President for 2014-15.
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 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.
During its 29th Annual Meeting, the North American Spine Society (NASS) launched the North American Spine Foundation, a non-profit organisation established to end spine-related disability through research, education and advocacy.
K2M has received Food and Drug Administration (FDA) 510(k) clearance to market the CAPRI corpectomy cage system, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy.
Globus Medical has launched its new minimally invasive fully articulating expandable spacer for spinal fusion - ALTERA.