A prospective randomised clinical study of Amniox’s Clarix regenerative matrix used as an adjunct to lumbar discectomy has found statistically significant improvements on Oswestry Disability Index and Short Form-12 (physical component scale) scores at six months and two years. The...
Signus has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new Diplomat pedicle screw system. The Diplomat has been developed in cooperation with international spine experts. As a posterior fixation system, it is intended to...
4Web Medical has announced that the first surgeries using the company's Curved Posterior Spine Truss system (PSTS) for transforaminal lumbar interbody fusion procedures have been performed. Jeffrey Wise, Blue Ridge Orthopaedic and Spine Center, who used the Curved PSTS upon...
During its 31st Annual Meeting, the North American Spine Society (NASS) announced the winners of its prestigious 2016 Recognition Awards. NASS presents four annual awards which recognise unique and outstanding contributions to the field of spinal care and research....
A nationwide analysis of metastatic bone disease—believed by the authors to be the first of its kind in the world—has found that cases of spinal metastasis have increased by 182% from 1994 to 2012. The study used the National...
Clinically-significant positive outcomes for the surgical treatment of adult spinal deformity have proven elusive for researchers, with many studies limited by the non-randomisation of participants. A new study from the European Spine Study Group, however, has found better clinical...
According to a new study presented at the 31st Annual Meeting of the North American Spine Society (NASS), tobacco use may harm the body’s healing response from surgery for cervical myelopathy based on number of cigarettes smoked over a...
The Spine Journal and the North American Spine Society (NASS) have announced three winners of the 2016 Outstanding Paper Awards at NASS’ 31st Annual Meeting. These awards recognise excellence in unpublished research in spine care. Winning manuscripts receive a US$10,000...
During the 31st Annual Meeting of the North American Spine Society (NASS), F Todd Wetzel was named NASS president for 2016-17. Wetzel is an orthopaedic surgeon who lives in Wilmington, USA and practices medicine in Philadelphia, USA. “As a NASS...
According to a new study presented at the 31st Annual Meeting of the North American Spine Society (NASS), high expectations of pain improvement before a common back surgery are actually associated with less pain improvement after surgery. “While a positive...
Spinal Elements has announced that it will be working with Mighty Oak Medical to market the Firefly surgical guidance system. The Firefly system consists of bone models and guides precisely matched to the patient’s anatomy through concierge pre-surgical planning and...
Spineology has announced the completion of 100 cases using its new Palisade pedicular fixation system. Palisade is one of several recent additions to Spineology’s Anatomy-Conserving Technology (ACT) product platform. “Reception of the Palisade system has been outstanding and we expect...
Image-guided surgery systems that provide real-time guidance for minimally invasive spine surgery can help improve patient outcomes, but these systems are costly for many hospitals. Surgeons may rely on checking implant placement with multiple static X-ray images that do...
Pinnacle Spine has announced the launch of its InFill V2 lateral interbody device, which features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain disc height and facilitates the formation of a...
Kern Singh, Midwest Orthopaedics at Rush University Medical Center, and his team have started to enrol patients for a clinical study on the FLXfit articulating and lordotic expandable cage (Expanding Orthopedics). Singh, associate professor, Rush University Medical Center, co-director Minimally Invasive...
DePuy Synthes Spine has announced the launch of the Zero-P Natural plate to help maintain stability and support bone growth in spinal fusion procedures in the neck. The Zero-P Natural plate is designed for use with the CC Natural...
Amniox Medical has announced results of a prospective randomised clinical study of its proprietary cryopreserved Amniotic Membrane as an adjunct to lumbar discectomy. The findings will be presented at the North American Spine Society 2016 annual meeting (26–29 October,...
Life Spine has successfully completed initial cases with its recently-launched Pro-Link Ti stand-alone cervical spacer system. Pro-Link Ti offers a low-profile, stand-alone cervical interbody, incorporating Osseo-Loc, a proprietary surface treatment for titanium which helps create an environment for potential...
The US Food and Drug Administration (FDA) has given clearance to Spineology’s Rampart Duo interbody fusion system. The Rampart Duo device is the first device of its kind to combine PEEK, titanium, and graft containment mesh elements, according to...
Millions of people take opioids for chronic back pain, but many of them get limited relief while experiencing side effects and worrying about the stigma associated with taking them, according to research presented at the Anesthesiology 2016 annual meeting...
Surgery for female adolescent idiopathic scoliosis patients appears to have no impact on complication rates for future pregnancy, according to data presented at the 51st Annual Meeting of the Scoliosis Research Society (SRS; 21–24 September, Prague, Czech Republic). While those...
An analysis of ≥10 year outcomes data for patients treated surgically for major thoracic adolescent idiopathic scoliosis (AIS) has found that 23% of the surgical outcomes in this cohort were “less than ideal”. The prospective study from the Harms...
Implementing a team-based approach to paediatric spinal surgery “significantly improves surgical and perioperative outcomes”, according to new research presented at the Scoliosis Research Society Annual Meeting (SRS; 21-24 September, Prague, Czech Republic). Even when researchers adjusted their results for...
Beth Israel Deaconess Medical Center in Boston, USA has been added as a clinical site for the INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS...
For patients with chronic back pain, "open" treatment with placebo—informing patients that they are taking an inactive pill, and why it might be helpful—leads to reductions in pain and disability, reports a study published in Pain. "This study is the...
Titan Spine has doubled its sales management team with the addition of nine new members. According to a company release, this is to meet the growing demand for its line of Endoskeleton products. Steve Cichy, vice president of Sales for...
The Medicrea Group has received two 510(k) clearances from the US Food and Drug Administration (FDA) for its Pass XS posterior fixation and LigaPass XS band connector components, designed to address paediatric spinal deformities in small stature patients. The company...
A randomised study has found reduced pre- and postoperative logistics times, as well as a complete elimination of logistics incidents, across 40 surgeries with the use of Safe Orthopaedics’ single-use products. This 1:1 randomised study was conducted by teams at...
Precision Spine will introduce its MD-Vue lateral access system at the North American Spine Society (NASS) Annual Meeting October 26-29 in Boston, USA. According to a company release, the system was designed in collaboration with prominent lateral approach spinal...
The Foothills Medical Centre in Calgary has been added as a Canadian clinical site for InVivo Therapeutics’ INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS...
SpineGuard is to launch its next-generation PediGuard “Threaded” device using the company’s Dynamic Surgical Guidance technology the 31st annual meeting of the North American Spine Society (NASS) in Boston, USA, October 26-29 2016. The PediGuard Threaded device with DSG is...
Spineology has obtained US Food and Drug Administration (FDA)-clearance for the use of allograft bone with its Rampart Interbody Fusion Devices. “This approval and our recent partnership expansion with Musculoskeletal Transplant Foundation (MTF) provides us the ability to pair MTF...
Researchers from the Ohio State University (Columbus, USA) have discovered that spinal cord injury alters the type of bacteria living in the gut, and that these changes can exacerbate the extent of neurological damage and impair recovery of function....
Zyga Technology has released 12-month fusion and clinical results for patients receiving SImmetry sacroiliac joint fusion with decortication. Study results were presented at the 2016 Society for Minimally Invasive Spine Surgery (SMISS) annual meeting (13-15 October 2016) by William...
Norgine Ventures BV has entered into a definitive agreement to acquire SpineVision SA, an integrated spinal technology company focused on the development and marketing of implants and instrumentation for spinal treatment. Arnaud Brisard, chief executive officer, SpineVision comments, “I am...
Mazor Robotics has announced that it received purchase orders for 25 systems during the third financial quarter of 2016, including pre-launch orders for the recently unveiled Mazor X, a transformative guidance platform for spinal surgeries. The Mazor X will...
ChoiceSpine has announced the appointment of Christy Cote as vice president of Biologics. According to a company release, she is a business leader with over 14 years’ experience in stem cell technology, surgical implants, and regenerative therapies. Prior to joining...
SI-Bone has submitted INSITE (Investigation of Sacroiliac Fusion Treatment) two-year randomised controlled trial data to Yale University's Open Data Access (YODA) programme. INSITE is a randomised controlled trial of minimally invasive sacroiliac joint fusion using the company’s iFuse devices, in...
The Charité–Universitätsmedizin hospital in Berlin, Germany has started to provide patient exams with its new EOS imaging system. Charité is a leading hospital in Germany with 17 different Charité centres in the Berlin area. Established over 300 years ago, Charité...
Bone Therapeutics has reported positive efficacy data for its phase IIA spinal fusion trial with Allob. Results of the first half of patients in the study show evidence of successful fusion and important clinical improvements in function, pain and...
Alphatec Holdings, the parent company of Alphatec Spine, has announced a reduction in the company's workforce and changes to the company's executive leadership team. Michael O'Neill, Alphatec's chief financial officer and treasurer, has resigned effective October 5, 2016. Dennis Nelson,...
Stryker’s Spine division has announced the launch of its Lite Bio delivery system, a hand-held device used to facilitate delivery of bone graft material to spinal surgery sites. It is designed to simplify graft delivery, accommodate a surgeon’s preferred...
K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) to expand its Cascadia lateral interbody system, featuring the company’s Lamellar 3D titanium technology. K2M’s Lamellar 3D titanium technology uses a 3D printing method to create structures...
Titan Spine has expanded the distribution of its line of Endoskeleton titanium implants featuring the company’s new proprietary NanoLock surface technology to all of the USA. The launch follows the alpha introduction of the NanoLock technology initiated recently in a...
The majority of US National Football League (NFL) players who undergo surgery for a herniated disc in the cervical spine are able to resume their careers and perform at a high level, suggests a study in Spine. Even players with...
US district court judge, Timothy S Black (Southern Ohio, USA) has dismissed the accusation of several hundred plaintiffs that they have been treated off-label with Medtronic’s Infuse. The plaintiffs were all former patients of Atiq Durrani (Cincinnati, USA), an orthopaedic...
Identifying frailty in older patients could increase their chances of surviving surgery, as well as improve their overall outcomes, according to a new study posted online in The Annals of Thoracic Surgery. “Patients with frail health have less ability to...
Studies have shown that activity-based interventions can offer a promising approach to the improvement of motor function following spinal cord injury. Sunil Agrawal, professor of mechanical engineering and of rehabilitation and regenerative medicine at Columbia Engineering (New York City,...
A Dutch cost-utility study published in The Spine Journal argues that implantation of interspinous process devices as an indirect decompressing measure is “highly unlikely to be cost-effective compared with bony decompression for patients with intermittent neurogenic claudication caused by...
Rafael De la Garza-Ramos (Monterrey, Mexico, currently resident at Montefiore Medical Center, Bronx, USA) and others report in the International Journal of Spine Surgery that vertebral augmentation, either through vertebroplasty or kyphoplasty, is associated with a significant reduction in...
Early bird registration for NSpine 2017 has opened, offering discounted registration until 30th November. NSpine is collaborating with the British Scoliosis Research Foundation and NuVasive to offer registration to the 15th International Philipp Zorab Symposium at a reduced rate. The collaboration...
The first subject has been enrolled in the ReActiv8-B Clinical Trial of the Mainstay Medical ReActiv8 device. The trial is intended to gather data in support of an application for pre-market approval from the US Food and Drug Administration...
The ApiFix system has now been used to correct scoliosis in 100 patients with a first case at the Paul Gerhardt Diakonie hospital in Berlin, Germany. The 100th case was Miguel Alquiza's first time implanting the ApiFix system. According...
Mainstay Medical has announced the one-year results from the ReActiv8-A Clinical Trial, an international, multi-centre, prospective, single arm trial for ReActiv8 in people with disabling chronic low back pain and few other treatment options. The one-year results show sustained performance...
Spineology has expanded its relationship with Musculoskeletal Transplant Foundation (MTF), the USA’s leading tissue bank. MTF will now be the sole tissue provider for Spineology’s allograft product lines, including the newly launched Incite cortical fibres, a unique and versatile...
Ulrich medical has announced the US market release of its uCerv titanium spinal implants as an adjunct to its current uCerv PEEK Optima interbody system, which is an existing product used for anterior cervical discectomy and fusion surgical procedures. "Spinal...

Marketing Manager at XYZ Medical

Company: XYZ Medical Position: Marketing Manager Contact: email@xyzmedical.com Application deadline: 26 September 2017 Job description: The marketing manager manages the day to day marketing activities of the organisation and long term marketing strategy for the company. Duties of the Marketing Manager include: Managing all marketing...
Band-Lok has announced the performance of the first spinal surgery using the company’s pedicle-sparing polyester band technology. Mike Albert performed the first case on August 22, 2016, at Dayton Children’s Hospital in Dayton, Ohio. “The technology’s unique tether clamp system...
NuVasive has received 510(k) clearance from the US Food and Drug Administration (FDA) for the company’s Magec system to be surgically implanted using its Reline posterior fixation system for treating patients with severe spinal deformity conditions. According to a company...
Life Spine has announced that the US Food and Drug Administration (FDA) has given 510(k) marketing clearance to the company’s Pro-Link Ti stand-alone cervical spacer system. The system features the company’s Osseo-Loc technology. “Osseo-Loc is a proprietary surface treatment for...
A small study from Inspired Spine has found a significant reduction in back pain following minimally invasive direct thoracic interbody fusion (MIS-DTIF). The study included four participants and measured patient-reported pain, surgery time and complications. Before surgery, patients reported an average...
K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) for screw and connector components for its Mesa spinal system. This clearance enables these screw and connector components to be used as a part of a...
Tuberculous spinal epidural abscess is an uncommon pathology that needs an urgent intervention to decompress pressure on the spinal epidural sac, cord and roots, writes Ghazwan A Hasan. Vertebral tuberculosis accounts for less than 1% of all tuberculosis infections. It...
A study from NSpine has shown that a majority of women experience problems in sexual function following anterior spinal surgery. The study, which was presented at Spineweek (Singapore; 16-20 May 2016) by Irene Hernandez-Sanchez (Birmingham, UK) during the “All...
Implanet has announced successful results for the first surgical procedures using the Jazz Lock. Having obtained CE marking and 510K clearance, Jazz Lock has been used in select hospitals in France, Italy and the USA. According to a press release,...
EOS imaging has sold an EOS system to the Carolinas HealthCare System (Charlotte, USA). The system will be located at a dedicated imaging centre in Carolina HealthCare’s Morehead Medical Plaza campus in Charlotte. According to a company release, it will...

Christopher Bono

Christopher Bono’s interest in surgery was piqued after watching live operations on television as a teenager. After training and working in New York, USA, Bono became involved in orthopaedic surgery and spinal research. During his career he has worked...
Vexim has signed an agreement with Creatori Health for the distribution of its portfolio in South Africa. Vexim’s portfolio gained reimbursement from one of the leading medical health insurance in South Africa. “With the support of Vexim, and the granted reimbursement...
Highlights:- Risk stratification is not a “universal language”, numerous IMAST presentations find - Posterior BMP-2 use does not lead to increased cervical deformity surgery-related complications - UHMWPE cable feature - Profile: Christopher Bono     https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/09/40-Spinal-News-low-res3.pdf
Chemists from Trinity College Dublin, (Dublin, Ireland) in collaboration with the Royal College of Surgeons in Ireland (RSCI), have devised a new scanning technique that can produce extremely high-resolution 3D images of bones without exposing patients to X-ray radiation. The...
A large Japanese study has found that a significant number of spinal stenosis patients using health insurance claims are elderly people (>80 years), with most receiving non-surgical treatment. The research was published in Spine. Lead author Izumi Kuboyama, The University...
Alphatec Holdings, the parent company of Alphatec Spine, has completed the sale of its international operations and distribution channel to Globus Medical. With the closing of the transaction, Alphatec is now focused solely on the US market. The company has...
Thomas J Hwang (Harvard University, Cambridge, USA, Brigham and Women’s Hospital and Harvard Medical School, Boston, USA) and others report in the British Medical Journal that medical devices that are approved in the European Union (EU) prior to being...
The use of computers to map the spine, to plan surgery, and to aid in the manufacturing of medical devices is becoming increasingly common in spinal surgery. Spinal News International speaks with Andrew G King about his experience with patient-specific rods (UNiD,...
A team of doctors from Keck Medical Center of the University of Sourthern California (Los Angeles, USA) have become the first in the US state of California to inject an experimental treatment made from stem cells, AST-OPC1, into the damaged...
Flakes of graphene welded together into solid materials may be suitable for bone implants, according to a study led by Rice University (Houston, USA) scientists. The Rice lab of materials scientist Pulickel Ajayan and colleagues in Texas, Brazil and India...
According to new research from the Hospital for Special Surgery in New York City, USA, 36.5% of patients undergoing surgical treatment for adult spinal deformity in the US Nationwide Inpatient Sample (NIS) has been coded with at least one...
Vexim has received regulatory approval from the Therapeutic Goods Administration to commercialise its SpineJack and the cement delivery system, Masterflow, in Australia. According to a press release, the company is expanding its international presence whilst preparing  the development of new...
Today, transcutaneous spinal fixation is efficient in terms of solidity and reduction. Achieving real fusion remains a problem, however, as does the successful navigation of each surgical approach. Fusion takes place, after all, at the hardest point to reach...
Whilst a number of studies have assessed the incidence of complications in association with posterior BMP-2 (bone morphogenetic protein-2) use, researchers from the International Spine Study Group noted that none focus on cervical deformity. Presented by Han Jo Kim...
On 17 August, a multicentre, randomised, double-blind, placebo-controlled trial—the VAPOUR trial—was published online ahead of print in The Lancet. Six-month data from the trial provide the first sham-controlled evidence in support of using the procedure. Data from VAPOUR (Safety and...
The variety of procedures in spinal surgery is extensive. While anterior and posterior open approaches are the conventional approaches, it is the posterior approach that is most frequently used. Traditionally, the open posterior exposure involves a central midline incision...
Minimally invasive approaches to spinal surgery can lead to less blood loss, faster rehabilitation and a reduction in patient scarring. However, these procedures may also lead to increased procedure times, higher doses of radiation and less surgical precision. The Artis zeego fixed...
AESCULAP®’s Plasmapore® titanium coating has evolved over the past thirty years. From its 1986 commercial introduction on the BICONTACT hip implant system to its 1995 application to the PROSPACE® posterior lumbar interbody fusion system, the surface coating has provided an ideal environment for...
This year’s Spineweek meeting (Singapore; 16–20 May) featured a number of presentations from F-MARC, the Fédération Internationale de Football Association (FIFA) Medical Assessment and Research Centre. Among the data presented at the meeting, one first-of-its-kind study found a significantly...
A study using US insurance data has shown the risk of complication and the incidence of novel lumbar pathology following minimally invasive sacroiliac joint fusion surgery to be higher than previously reported in the literature. This respective study—currently in...
The US Patent and Trademark Office (USPTO) has granted a patent for the Jazz platform to Implanet. This protects the company’s intellectual property until 2032. The Jaz platform’s intellectual protection now covers the braided implant and its tensioning system, the...
Initial cases have been successfully completed with Life Spine’s Sentry lateral plate system. The product is designed to offer a low profile, intuitive design with a cam-locking mechanism, intended to provide visual, tactile and audible confirmation of final locking. “The...
OrthoPediatrics has launched its new BandLoc 5.5/6mm system, which has been both CE-marked and US Food and Drug Administration-approved. BandLoc is designed to offer a pedicle-sparing, band passage technique for treating a wide variety of complex spinal pathologies, including scoliosis....
Tyber Medical has launched their lateral plating system commercially. Through the use of new and patented features, the implant is designed to provide three points of fixation in each vertebral body, eliminating some of the instrumentation required by other systems,...
Spinal Simplicity has launched a new generation of Minuteman G3 fusion device, featuring a US Food and Drug Administration (FDA)-cleared coating of hydroxyapatite. "Hydroxyapatite has been used in orthopaedic procedures for the last 30 years because of its successful track...
SeaSpine has entered into a definitive agreement to acquire all assets of NLT Spine, an Israel-based medical device company developing spinal products for minimally invasive surgery. NLT’s platforms include vertical, lordotic and footprint expanding interbody technologies for use in lumbar...
CTL Medical has established a General Services Administration (GSA) partnership with Firehouse Medical to sell its line of innovative spinal implants and devices to the US government. GSA contracts allow commercial companies to establish long-term, government-wide contracts and sell...
The ninth spinal cord injury patient in the INSPIRE trial—implanted with InVivo Therapeutics’ neuro-spinal scaffold last month—is showing signs of improvement. The patient is the fifth of eight patients in the company’s study to show an American Spinal Injury...
Medtronic has completed the second tranche of a previously agreed equity investment in Mazor Robotics. According to a press release, the triggering milestone for this second tranche investment was the July 12, 2016 unveiling by the company of Mazor X. “Since...
Medicrea has appointed Richard Kienzle as chief commercial officer and business development officer. Kienzle will also join Medicrea’s board of directors. Kienzle is best known as a founding member of Globus Medical. “I am…excited to welcome Rick Kienzle to the...
The US Food and Drug Administration (FDA) has cleared an expanded range of Valeo II lateral lumbar sizes (Amedica). The additional sizes of the Valeo II LL interbody fusion device will be commercially available August 29, 2016. The Valeo II...
NovaBone has received the Brazilian ANVISA Good Manufacturing Practices (GMP) medical device certificate. ANVISA is Brazil's equivalent to the US Food and Drug Administration (FDA), and is responsible for the oversight of all medical device and pharmaceuticals in the Brazilian...
As part of an ongoing collaboration between Rensselaer Polytechnic Institute (Troy, USA) and the Icahn School of Medicine at Mount Sinai (New York City, USA)—a partnership that draws upon the expertise of both schools to address significant health problems—researchers...
SI-Bone has announced the publication of two-year results from INSITE (Investigation of Sacroiliac Fusion Treatment) a landmark prospective, multicentre, randomised controlled trial of minimally invasive sacroiliac joint fusion with iFuse compared to non-surgical management. Results of this level 1...
Titan Spine has expanded its distribution agreement with strategic partner MBA to provide its line of Endoskeleton titanium implants to practicing spinal surgeons in Italy.   Under the agreement, initially announced in September 2015, Titan Spine provides its spinal interbody fusion...
Spinal Elements has received 510(k) clearance from the USA Food and Drug Administration (FDA) to market an interspinous process device.  Spinal Elements’ device includes enhancements designed to make the device more accommodating to patient anatomy while streamlining the surgical procedure....
Decompression of lumbar spinal stenosis using the traditional laminectomy technique leads to good improvement of neurogenic claudication symptoms. However, impairment of facet joint and posterior tension band integrity can result in segmental instability and a significant reoperation rate, particularly...
A study published in the Journal of Neurology: Spine has found that “patients who undergo adult spinal deformity surgery at a teaching hospital may have significantly decreased odds of developing a postoperative complication”, in comparison with patients treated at...
The benefits and challenges of risk stratification research in spinal surgery were explored in detail during the 2016 International Meeting on Advanced Spinal Techniques (IMAST; 13-16 July, Washington, DC, USA) with presenters noting again and again the difficulties in...
RTI Surgical has announced that Brian K Hutchison has is to retire from his position as president and chief executive officer of the company, and step down from the board of directors. Hutchison has agreed to remain in his...
Nusinersen, an investigational treatment, has been shown to significantly improve achievement of motor milestones in babies with infantile-onset spinal muscular atrophy, according to an interim analysis of the double-blind, randomised, placebo-controlled Phase 3 clinical trial, ENDEAR. Thirty-six centres around the...
Cold plasma could help bones heal faster, according to a study published in the Journal of Tissue Engineering and Regenerative Medicine. Since the discovery of cold plasma, about 20 years ago, it has been used in agriculture to sterilise the...
Precision Spine will introduce its MD-Vue lateral access system at the North American Spine Society Annual Meeting (NASS: October 26-29 2016, Boston, USA). According to a press release, the strong, lightweight system was designed in collaboration with lateral spinal surgeons,...
InVivo Therapeutics Holdings has appointed Pamela Stahl to the newly-created position of chief commercial officer, effective September 14, 2016. Prior to joining InVivo, Stahl served for 10 years in various roles of at UnitedHealthcare, most recently as chief executive officer,...
Eight people who have spent years paralysed from spinal cord injuries have regained partial sensation and muscle control in their lower limbs after training with brain-controlled robotics, according to a study published in Scientific Reports. The patients used brain-machine interfaces,...
According to the National Spinal Cord Injury Statistical Center, there are approximately 282,000 people currently living with a spinal cord injury in the USA. “Spinal cord injury significantly alters a person’s way of life,” says Michelle Meade, associate professor of...
Intralink-Spine, is pleased to announce that early clinical study data has been obtained regarding the use of its Réjuve system for the treatment of low back pain. Each of the four patients treated in late June by orthopaedic surgeon Harwant...
There is a high rate of prescription pain reliever abuse in Europe, largely accounted by opioids, according to the first comparative study of prescription drug abuse in the European Union (EU), which was conducted by researchers at RTI International...
Camber Spine has partnered with Joseph DiCicco of Orthopedic Trauma Associates of Southwestern Ohio (Dayton, USA) to conduct a postoperative pain study on patients receiving the Prolix implant. Patients in the study have undergone pain management therapy for sacroiliac pain...
Twenty-four month data from a postmarket, clinical registry have found that most patients suffering from chronic pain of the trunk and/or limbs reported “substantial” pain relief following implantation of a spinal cord stimulation system. The 24-month clinical outcome study...
Spineart has received 510(k) clearances from the US Food and Drug Administration to market its new Juliet Ti lumbar interbody systems in the USA. The Juliet Ti PO, OL and TL interbody systems are the first range of titanium...
A research team at the Krembil Research Institute (Toronto, Canada) has discovered a pair of tissue biomarkers that directly contribute to the joint degeneration associated with spinal osteoarthritis. The study, published in the Journal of Clinical Investigation Insight, is the...
The president of the American Medical Association—Steven J Stack—has issued an open letter to US physicians about the country’s opioid epidemic. Entitled, “Confronting a crisis: An open letter to America’s physicians on the opioid epidemic”, encourages physicians to confront widespread...
See the highlights from the 1st International Conference on Sacroiliac Joint Surgery as we prepare for the 2nd conference on 16-17 September in Hamburg, Germany. Sacroiliac Medical Expert Group (SIMEG) e.V., based in the Cologne area/Germany announce their 2nd annual...
Spinal Elements has announced that over 10,000 Ti-Bond interbody devices have been implanted. To celebrate this milestone a Ti-Bond warranty programme has been initiated. Ti-Bond is the name of Spinal Elements’ porous titanium coating, applied to PEEK interbody devices. The Ti-Bond...
DeGen Medical has received clearance from the US Food and Drug Administration (FDA) for its F1 modular pedicle screw system for the company’s Joust minimally invasive surgery procedure. The Joust minimally invasive technology is a modular pedicle screw with...
A paper published in the European Journal of Spine has demonstrated the effectiveness of Orthofix’s Trinity Evolution bone graft for single-level anterior cervical discectomy and fusion in combination with a PEEK interbody spacer and supplemental anterior fixation. The 12-month study...
4WEB Medical has received 510K clearance from the FDA for its lateral interbody fusion device, the Lateral Spine Truss system. Frank Cammisa, professor and chief emeritus of the Spine Service at Hospital for Special Surgery in New York City, says,...
Orthofix has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its Phoenix minimally invasive spinal fixation system. Ray Fujikawa, president of Orthofix Spine Fixation says, “We are committed to continuing to work towards securing additional...
Ortho Kinematics has launched the VMA-Align product. VMA-Align is a new vertebral motion analysis diagnostic module and service offering. According to a company release, VMA-Align gives spinal surgeons an unprecedented level of data to assist in patient selection and planning...
Relievant Medsystems has received US Food and Drug Administration (FDA) 510(k) clearance for the Intracept intraosseous nerve ablation system. According to a company release, the Intracept system is the first specific therapy to relieve chronic low back pain care—caused by...
The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. According to an email from the consumer watchdog, the document is intended to clarify “how...
SpineCraft has launched the Astra system, designed for spinal deformity correction, tumour, trauma and degenerative procedures. The system also includes a new revision and extension module developed for the expanding revision patient population. The revision & extension module includes a...
Data from two studies have demonstrated significant clinical benefits associated with the Mazor Robotics Renaissance surgical guidance technological platform. The data was presented during the 23rd International Meeting on Advanced Spine Techniques annual meeting in Washington, D.C, USA (IMAST:...
The US Food and Drug Administration has cleared NeuroPro’s Spinal Jaxx expandable intervertebral spacer. Spinal Jaxx is an expandable lumbar interbody fusion device for spinal surgeries. The design of the spacer and proprietary tool set are intended to allow surgeons...
EOS imaging is to partner with Anatoscope, to combine the company’s virtual patient models with EOS’ 2D/3D images and datasets, into the EOS apps for advanced orthopaedic applications. The first applications are due for release in 2017. Anatoscope, a start-up...
A pre-clinical study, conducted by Amanda LoGuidice, University of Florida, USA, has shown that multipotent adult progenitor cells on an allograft scaffold can facilitate the bone repair process. The research has recently been published in the Journal of Tissue...
A patch made from cryopreserved human umbilical cord may be a novel method for treating spina bifida in utero, according to researchers at McGovern Medical School at The University of Texas Health Science Center in Houston (USA). The findings...
ulrich medical USA has released the neon3 posterior cervical system, which is intended to provide immobilisation and stabilisation of spinal segments as an adjunct to fusion or for a number of acute and chronic instabilities of the cervical and...
Spineart has received CE marking for its new Juliet Ti lumbar interbody systems. The Juliet Ti PO, OL and TL interbody systems are the first range of titanium interbody implants featuring the company’s proprietary Ti-LifeTechnology. Ti-LifeTechnology micro-porous scaffold is designed to...
Zimmer Biomet has announced a multi-year collaboration with the Indo UK Institutes of Health (IUIH), intended to increase the capacity of India's healthcare infrastructure.  The first phase of the collaboration involves the establishment of the Zimmer Biomet Institute of India,...
Results from a multicentre European prospective registry for the Baguara C prostethic cervical disc (Spineart) have shown good mobility at the treated and adjacent levels, disc height restoration and clear evidence of adjacent levels preservation. The retrospective analysis of a...
Spine Wave has launched its True Position pivoting spacer system in the USA, following a limited release of the device. The system was acquired by the company in February 2016, from Atlas Spine. The True Position pivoting spacer system is...
Data from a study published in Spine have shown that K2M's Mesa Rail deformity spinal system could result in significantly better major curve correction than standard circular rod constructs. Mesa Rail features a beam-like design that provides enhanced rigidity to...
The US Patent Office has granted US patent 13/923,577 to Graftys, covering GRFT-R02—an osteogenic biomaterial for bone tissue regeneration. This is the 8th patent granted to the company or to its licensors. It results from a large collaboration between Graftys...
In a retrospective study of medical records, researchers at Johns Hopkins Medicine have concluded that growing-rod treatment for children with severe, early-onset scoliosis can be eliminated in many cases. "We have long thought this big final fusion surgery, after years of spine...
KB Medical has appointed Steve Swinson to its Board of Directors. Accordiung to a company release, Steve Swinson has over 30 years of international experience in the healthcare sector, especially in the area of medical device technology and capital equipment. Formerly...
The US Food and Drug Administration (FDA) has cleared Medtronic’s CD Horizon fenestrated screw set. This marks the first US clearance for cement-augmented pedicle screws. The product can be used for patients diagnosed with advanced stage tumours involving the thoracic...
Zimmer Biomet Holdings has successfully completed its offer to purchase all outstanding shares of LDR’s remaining common stock for US$37.00 per share. David Dvorak, president and chief executive officer of Zimmer Biomet, comments, "We are excited to officially welcome LDR...
According to a press release, preclinical data on adipose-derived mesenchymal stem cells—presented by Nicole Ehrhart, professor of Surgical Oncology at the Colorado State University (CSU) Flint Animal Cancer Center (Fort Collins, USA), at the State of Spine Surgery 13th...
Precision Spine has named Christopher A DeNicola its new chief operating officer. “Chris is a seasoned leader in the orthopaedic medical device industry and he has been instrumental in building our domestic and international distributor network, as well as governing...
Phygen has received a Notice of Issuance for its latest interspinous device as an additional device for use in the treatment of spinal disease and conditions.  This is the first patent issued for the La Costa interspinous line, which includes...
NuVasive and Medtronic have reached agreement on terms for the settlement of patent infringement lawsuits between the companies, as well as the withdrawal from related proceedings in the United States Patent and Trademark Office. NuVasive is to make a one-time...
NuVasive, has completed its acquisition of Biotronic NeuroNetwork, a provider of intraoperative neurophysiological monitoring services. Gregory T Lucier, chairman and chief executive officer of NuVasive, says, "We are very excited to announce the completion of the Biotronic acquisition...We are confident...
A wholly-owned subsidiary of Zimmer Biomet has acquired 1,406,151 Medtech shares, representing 58.77% of the outstanding share capital of Medtech, from Bertin Nahum, Newfund and certain other selling stockholders in a private transaction, as well as all outstanding convertible...
Medtech has announced the sale of thirteen new Rosa robots during the fourth fiscal quarter 2016 (April 1 to June 30, 2016). Of the thirteen robots, seven were sold in the USA, two in France, two in China, one in...
The INSPIRE study of InVivo Therapeutics’ Neuro-spinal scaffold—originally approved to enrol 12 patients—has been granted permission to expand to 20 patients, following the US Food and Drug Administration’s (FDA) review of six-month safety data from the first five patients...
The UK’s Masonic Charitable Foundation has awarded £65,000 to the Inspire Foundation to fund a research project which aims to improve the quality of life and independence of people with spinal cord injuries. The research project will be led by...
The first implantation of Camber Spine Technology’s Enza minimally invasive zero-profile anterior lumbar interbody fusion (ALIF) device in a two-level lumbar procedure at levels L4/L5 and L5/S1 has taken place. The procedure was performed at Kennedy University Hospital (Washington Township,...
Bone Biologics has appointed Scott Boden as chief medical advisor.  Boden is a tenured professor of Orthopaedic Surgery at the Emory University School of Medicine (Atlanta, USA) and serves as the director of the Emory Orthopaedics & Spine Center,...
Scientists have designed technology to grow 3D bone in the lab–not with chemicals or drugs, but with vibration. The team, from the University of the West of Scotland (Paisley, Scotland) and the University of Glasgow (Glasgow, Scotland), has combined stem...
SI-Bone has announced the publication of the 40th peer-reviewed paper on sacroiliac joint fusion with its iFuse device. The paper shows a mean 3.7-year follow-up for minimally invasive sacroiliac joint fusion was associated with improved pain, low disability scores,...
The US Food and Drug Administration (FDA) has approved the Prestige LP cervical disc for the treatment of cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the C3-C7 segments of the neck. The...
Researchers at the Stanford University School of Medicine (Stanford, USA) have mapped out the sets of biological and chemical signals necessary to quickly and efficiently direct human embryonic stem cells to become pure populations of any of 12 cell...
The US Centers for Medicare & Medicaid Services (CMS) has created of a new technology International Classification of Diseases, Revision 10 (ICD-10) code for a nanotextured surface on an interbody fusion device. Titan Spine have announced that the company’s nanoLOCK...
Medtronic has launched the Pivox oblique lateral spinal system with lateral plate for OLIF25 and Divergence-L anterior/oblique lumbar fusion system for OLIF51 at the 2016 International Meeting on Advanced Spine Techniques (IMAST) in Washington, DC, USA. According to a company...
EOS imaging has announced a corporate agreement with the Schön Kliniken Hospital Network to supply EOS systems. Two EOS units have already been acquired by sites within the Schön Klinik network earlier this year. There are 17 Schön Kliniken hospitals...
Merit Medical has announced the acquisition of Dfine, in a merger transaction through which Dfine has become a wholly-owned subsidiary of Merit. The purchase consideration was approximately US$97.5 million in cash and was financed by a group of banks...
Medtronic has launched Spine Essentials—a new platform of spinal implants and instruments designed to make common cervical spine fusion procedures more efficient and cost-effective—in the USA. The system was launched at the Ambulatory Surgical Center Association (ASCA) annual meeting in...
Mazor Robotics has unveiled Mazor X, a new guidance platform for spinal surgeries. Mazor recently signed a commercial co-promotion and co-development agreement with Medtronic. As part of the agreement, Medtronic has placed a purchase order for 15 Mazor X...
Minimally invasive procedures utilising fluoroscopy are becoming increasingly popular. Little research has been performed, however, on the impact of patient body mass index on radiation dosage. A prospective study from Keio University School of Medicine (Tokyo, Japan) has found that...
SpineCraft has received clearance from the China Food and Drug Administration (CFDA) to market its Apex spine system in territory. The Apex System is designed for complex deformity correction as well as tumor, trauma and degenerative procedures. According to a...
Pierre Dumouchel’s term as interim chief executive officer has been made permanent, according to a press release from Safe Orthopaedics. The Board of Directors has decided to confirm his position, following his initial appointment in March 2016. According to the release,...
Amendia has launched the Ceres midline cervical plate. The Ceres midline cervical plate system is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. It is indicated for degenerative disc disease, spondylolisthesis, trauma, spinal...
EOS imaging has sold an EOS system to Advocate Good Samaritan Hospital in Downers Grove, USA. The hospital is a member of Advocate Healthcare, a hospital network which performs more than 18,000 hip, knee and spinal procedures per year. Advocate...
A cohort study has found that medical devices approved first in the European Union (EU) are associated with a greater rate of post-marketing safety alerts and recalls compared with devices approved first in the USA. First author Thomas J Hwang...
Scientists have developed biodegradable polymer grafts that, when surgically placed in damaged vertebrae, should grow to be just the right size and shape to fix the spinal column. The researchers present their work today at the 251st National Meeting &...
CTL Medical has announced the executive management team that it believes will lead the organisation into the next phase of growth. “We have a solid group of executives that we have brought into management roles,” says Daniel Chon, president and...
Highlights:- Adding fusion to decompression fails to improve clinical outcomes in treatment of lumbar stenosis - Five-year data suggest limited cervical arthroplasty benefits - Intraoperative navigation feature - Profile: Virginie Lafage     https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/06/39-Spinal-News-low-res-2.pdf  
Jack E Zigler, Texas Back Institute, Plano, USA, and Louis G Jenis, Massachusetts General Hospital, Boston, USA, debate the benefits and pitfalls of hybrid and fusion approaches to two-level lumbar degenerative disc disease. Jack Zigler: Lumbar hybrids for two-level lumbar...
Intraoperative navigation is becoming more and more popular with the advent of minimally invasive spinal surgery. Whilst uptake of the technology is limited by start-up costs, it can potentially benefit screw placement accuracy and rates of surgical revision. Charles...
Safe Orthopaedics is expansion into the Latin American market under distribution agreements covering Mexico and Chile. After securing regulatory marketing approvals in Australia and New Zealand in April, Safe Orthopaedics plans to continue expanding internationally. Safe Orthopaedics’ products have just received...
Bioventus has announced the appointment of Michael Minogue, chief executive officer, president and chairman of Abiomed, to the company’s Board of Managers, replacing Evan Melrose. “We are pleased to have Michael Minogue join our Board as we continue to grow...
Jeff Dunkel, vice president of strategic partnership at Titan Spine, talks exclusively to Spinal News International about his appointment to the Executive Operations Committee of the Medical Device Epidemiology Network Initiative. What kind of responsibility does the MDEpiNet Executive Operations...
Aurora Spine has received US patent number 9,364,264, entitled "Dynamic and Non-Dynamic Interspinous Fusion Implant and Bone Growth Stimulation System". This patent covers Aurora’s family of Zipinterspinous process devices, including its Zip Ultra, Zip 51, Zip LP and Dyna-Zip,...
The United States Patent and Trademark Office (USPTO) has granted a fundamental patent (US Patent 9,370,431) covering the practice of administering any spine deformation therapeutics to a patient having a spine deformation altered risk associated biomarker to Predictive Technology. "We...
A case report detailing the first clinical Invivo Therapeutics’ Neuro-spinal scaffold implantation has been published in Neurosurgery. Nicholas Theodore is the lead author of the article, which describes the clinical presentation, surgical procedure, and postoperative improvement of the first patient...
Life Spine has successfully completed initial cases with its Longbow expandable lateral spacer system. According to a company release, the product is the first interbody on the market that expands laterally (A/P) in-situ specifically for a direct lateral approach....
Spinal Elements has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a line of expandable interbody fusion devices.  The clearance includes expandable interbody devices for posterior, anterior, and lateral access to the lumbar spine. The...
Conducted at nine clinical centres in the United States, the trial enrolled 146 patients with chronic low back pain. AB001 also achieved statistically significant analgesia against placebo at week 1 (p=0.024), greater reduction than placebo in the mean Roland-Morris...
Kee D Kim explores new one-year outcomes data supporting the use of interspinous process fixation as an alternative to the use of pedicle screws. Do we still need to use pedicle screws as an adjunct to interbody fusion? Supplemental pedicle...
Surgical technologies are becoming more diverse and more easily accessible. Most do not have true added value, but others, like neuromonitoring for complex deformity procedures, are now incorporated in day-to-day practice, and have become standard of care, writes Nicolas...
Centinel Spine has completed the alpha release of its Stalif L no-profile, lateral lumbar integrated interbody device. According to a press release, Stalif L is the only lateral device to offer the benefits of no-profile, compressive lag fixation with proprietary...
Exactech has begun the full launch of its Acapella One cervical spacer system. The cervical cage pre-assembled with integrated anchors is designed to enable surgeons to restore disc height, while providing integrated fixation to prevent device migration during anterior cervical spinal...
Blue Cross Blue Shield has denied coverage for high frequency spinal cord stimulation in at least two states. Outposts of the federation of health insurance organisations in Tennessee and Pennsylvania (both USA) consider HF-10 spinal cord stimulation to...
As of 1st June 2016, more than 15,000 Baguera C have been successfully implanted worldwide. The first surgery was held in France in January 2007. According to a company release, the Baguera C’s anatomical shape, shock-absorption, guided mobile nucleus and...
SeaSpine has announced the full commercial launch of its Hollywood VI NanoMetalene transforaminal lumbar interbody fusion device. Hollywood VI NanoMetalene is indicated for use in spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with...
According to a press release from Mazor Robotics, Ronald Lehman has become the first person in New York City, USA, to perform a PROlat procedure using the Mazor Robotics Renaissance Guidance System. Lehman used the technology to assist in a...
SpineCraft reports it has completed 15,000 Apex spine system surgeries globally. The instrumentation system is designed for complex deformity correction as well as tumour, trauma and degenerative procedures. Anis Mekhail of the University of Illinois Hospital and Parkview Orthopaedic Group says,...
KB Medical has received CE marking certificate for its AQrate robotic assistance system, indicated for precise positioning of surgical instruments and spinal implants during general spinal surgery. According to a company release, KB Medical has developed a hardware and software...
Spineology has released the Elite expandable interbody fusion system. The Elite expandable interbody fusion system is designed to be implanted at a minimal height and expanded after final positioning in the disc space. This is intended to enable the surgeon...
Medicare Administrative Contractor (MAC), First Coast Service Options (FCSO), which covers the state of Florida as well as Puerto Rico and the US Virgin Islands, has established coverage criteria for minimally invasive sacroiliac joint fusion. This is the last...
SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new PediGuard Threaded DSG (Dynamic Surgical Guidance) device. “We are very excited by the clearance of our PediGuard Threaded device, which brings a new generation...
Geisinger Health Plan, a commercial health plan covering more than 500,000 individuals in the US states of Delaware, Maine, New Jersey, Pennsylvania, and West Virginia has issued a revised medical policy for sacroiliac joint fusion that exclusively covers the...
Amedica has submitted its responses to the US Food and Drug Administration (FDA) in relation to the CASCADE clinical trial. The CASCADE study compared the 24-month outcomes from single-level cervical fusion between Amedica’s porous silicon nitride versus bone autograft. Data...
The US Food and Drug Administration (FDA) has cleared a 510(k) to allow modification of Si-Bone’s indication statement for iFuse, noting that clinical studies have demonstrated treatment with the system can improve pain, patient function and quality of life. The...
Titan Spine is to provide a free replacement if any of the company’s Endoskeleton interbody fusion devices delaminate or generate particulate debris during implantation, updating the product warranty. According to a company release, the amended warranty reflects Titan Spine’s confidence...
Medicrea has recently partnered with Children’s Hospital (New Orleans, USA) orthopaedic surgeon, Andrew G King, to speak on his experience using Medicrea’s UNiD rods for customised spinal surgeries. This comes shortly after the US Food and Drug Administration (FDA) approval...
A new study in zebrafish by researchers at Princeton University and the University of Toronto suggests that irregular fluid flow through the spinal column brought on by gene mutations is linked adolescent idiopathic scoliosis. Also found in people, these...
An international, large-scale multicentre study of 33 spine institutes indicates that facet joint tropism—also known as facet joint angulation asymmetry—may be developmental in origin or may be a combination of developmental aspects and secondary changes of degenerative effects. This...
This drawing depicts plans to recognise the newly named Exactech Arena at the Stephen C O’Connell Center, a sports and entertainment complex at the University of Florida in Gainesville, USA. The remodelled facility is scheduled to re-open in December 2016.  Exactech...
LDR has announced the initial implantations of the ROI-C titanium-coated cervical cage. The first surgeries were performed by Mark Giovanini, a board-certified neurosurgeon specialising in minimally invasive spine surgery in Pensacola, USA, and Neil Romero, a board-certified orthopaedic surgeon...
InVivo Therapeutics has appointed Christina Morrison to its board of directors effective immediately. Most recently, Morrison served as the senior vice president of finance for Aramark. She joined Aramark in June 2013 as senior vice president of finance. Mark...
ChoiceSpine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market titanium lumbar interbody fusion devices. A ChoiceSpine press release states that the company now plans to offer titanium interbody devices for traditional PLIF (posterior lumbar...
Avitus Orthopaedics has launched pilot sales of its Avitus bone harvester product following the receipt of its 510(k) approval. The Avitus bone harvester, which has received 510(k) clearance from the US Food and Drug Administration as a class II medical...
CTL Medical has announced the executive management team that will lead the organisation into the next phase of its growth. “We have a solid group of executives that we have brought into management roles,” said Daniel Chon, president and...
Health Outcome, a consumer website focused on bridging the information gap for treatment outcomes, has launched the first crowdsourcing platform for patients to rate their treatment experiences and help others find evidence based cures. Health Outcome is currently the largest...
New York City’s Hospital for Special Surgery has acquired a third EOS system. The hospital installed its first EOS in 2013 for paediatric cases and its second EOS in 2015 for adult cases. The third EOS system will be dedicated...

Virginie Lafage

Virginie Lafage entered the world of spinal research by chance, after an engineering project drove her to a biomechanics lab in Paris, France. Since then, she has moved to the USA, become an executive member of the International Spine...
Screw placement accuracy is a critical point in instrumented spinal fusion, especially in difficult deformity cases There is a real, established risk of pedicle screws malposition and related complications, reported in literature at a range of 8–30%, writes Claudio...
Seeking to “go beyond the evidence presented by randomised control trials”, a group of researchers has used the international Spine Tango registry to compare the results of randomised control trials with those of real-world patients treated by either single-level...
NuVasive has entered into a definitive agreement to acquire Biotronic NeuroNetwork, a company which provides intraoperative neurophysiological monitoring services. NuVasive will acquire the company for US$98 million. According to a press release, NuVasive hopes that this acquisition will enhance its portfolio...
Age-related injuries such as femoral neck fractures often result in care dependency. However,  it does not necessarily have to be that way, suggested Tim Pohlemann (Saarland University Medical Center, Hamburg, Germany) at the 17th EFORT Annual Congress (1–3 June,...
Zimmer Biomet and LDR have announced a definitive agreement under which Zimmer Biomet will acquire all of the outstanding shares of LDR. The purchase price has been agreed at US$37.00 per share in cash, which implies a transaction value of...
Vertera Spine has announced the first wave of implantations with the Cohere cervical interbody fusion system. Cohere features the company’s patented porous PEEK (polyether ether ketone) Scoria biomaterial technology. According to a press release, Cohere is the first device in...
The US Food and Drug Administration (FDA) has finalised its efforts to streamline the “compassionate use” process, used by physicians to access investigational drugs and biologics for patients with limited treatment options. A statement from Robert Califf, the deputy...
A new bill introduced to the US Senate by Senator Dan Coats seeks to address the gap between the US Food and Drug Administration (FDA)’s priority review process for breakthrough medical devices, and the Centers for Medical and Medicare...
The entire platform of interbody products from Tyber Medical has been accepted into the Australian Registry of Therapeutic Goods. According to a Tyber Medical press release, Therapeutic Goods Administration approval—along with product reimbursement codes—ensures straightforward access to products in the...
Eden Spine’s Sphynx plating system has been granted CE mark approval. Made of titanium, the low profile Sphynx is intended to be implanted via the anterolateral approach for the treatment of thoracolumbar instabilities. Indications include spinal fractures, vertebral tumours, secondary...
The US Food and Drug Administration has granted 510(k) clearance to Additive Orthopaedics for its 3D-printed titanium digital fusion implant. "Additive manufacturing allows us to develop complex geometries at reasonable manufacturing costs not possible before now with traditional manufacturing," says Greg...
Whilst intraoperative fluoroscopic navigation may offer a number of benefits to spinal surgery, uptake in the field is still relatively low. Jeff McConnell talks to Spinal
 News
 International about the limits of this technology. What can intraoperative fluoroscopic navigation enable physicians to...
Life Spine has reported that the first cases have been successfully performed with the company’s Plateau-Ti spacer system. Plateau-Ti is a titanium interbody system using Osseo-Loc, a surface treatment with 500-600 microns of porosity designed to help create an environment...
Implanet has nominated Mary E Shaughnessy as its new Board director. Drawing on 20 years of experience working for Partners Healthcare System in Boston, Shaughnessy’s specific expertise lie in the healthcare finance and reimbursement sector. She was senior vice president...
Pinnacle Spine has launched its InFill anterior lumbar interbody fusion (ALIF) interbody device. The device is designed to maximise wall thickness and graft chamber volume, ensuring optimal contact with the vertebral endplates by both the interbody device and bone...
K2M has received 510(k) clearances from the US Food and Drug Administration (FDA) to market its Cascadia cervical and the Cascadia AN lordotic oblique interbody systems featuring Lamellar 3D titanium technology. This is intended to allow for bony integration...
The Netherlands presidency of the European Council and representatives of the European Parliament have reached a political agreement on two draft regulations for medical devices. The new regulations are aimed at ensuring that medical devices and in vitro diagnostic...
Ortho Kinematics has received Health Canada authorisation for its Vertebral Motion Analysis “VMA” product. The VMA is now licensed for sale in Canada, expanding the VMA’s current list of markets, which include the USA and Europe. The VMA is a...
Centinel Spine has expanded its Midline II-Ti product range—a Ti-Active coated, no-profile, anterior lumbar integrated interbody device—in the USA and Australia. Midline II-Ti is the sixth generation of the company’s Stalif technology. According to a company release, Midline II-Ti integrates...
The US Food and Drug Administration has cleared Interventional Spine’s 80 lumbar lordotic Opticage expandable intervertebral body fusion device The lordotic 80 Opticage is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in...
The first InterLink product is a pedicle fixation system. The system is made in the USA and includes of 22 polyaxial pedicle screws, 19 spinal rods, cross-connectors, and set screws, and can be used for single or multiple level...
Two presentations at the annual conference of the International Society for the Advancement of Spinal Society (6–8 April; Las Vegas, USA) have revealed potential benefits for cervical disc arthroplasty over anterior cervical discectomy and fusion (ACDF). Both using prospective,...
Rates of low back pain in the developing world have surpassed those of the developed world, with its prevalence growing in urban populations. A cross-sectional population-based study of 22,952 participants residing in Tehran, Iran, published in Spine, has found...
Mainstay Medical International has received CE mark approval for ReActiv8, its proprietary implantable neurostimulation system designed to treat disabling chronic low back pain. According to a press release, the CE mark approval is based on positive results from the ReActiv8-A...
NuVasive has added the AttraX putty to its US biologics range. AttraX Putty is a next-generation, synthetic bone graft product indicated for use as an autograft extender in posterolateral spine surgery. The biotextured surface features of AttraX putty is designed...
 Implanet has been granted US Food and Drug Administration (FDA) 510(k) and CE mark in Europe to market its new Jazz Claw implant. Jazz Claw is a hybrid implant providing autostable posterior fixation, intended to replace traditional hook-and-screw fixation systems....
The first surgical operation with the Rosa Spine (Medtech) in Spain has taken place. The procedure, which was performed at Hospital La Fe of Valencia, treated a patient with degenerative disc disease. The operation was performed on a 47 year-old...
Medtronic has launched the Spine Essentials platform in the USA. This is a new platform of spinal implants and instruments designed to make the most common cervical spine fusion procedures more efficient and help hospital systems manage costs, while...
Boston Scientific Corporation has launched the Precision Montage MRI spinal cord stimulator system after receiving approval from the US Food and Drug Administration (FDA). The Precision Montage System offers customised relief to patients with chronic pain while also enabling...
The European Spine Journal has published six-month results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis). iMIA is a randomised controlled trial conducted in Europe to measure the safety and effectiveness of minimally invasive sacroiliac joint fusion using iFuse (SI-Bone) implants, compared to conservative management...
Orthofix International has received US Food and Drug Administration 510(k) clearance, and announced the US limited market launch of the Forza PTC (PEEK titanium composite) spacer system. Designed and manufactured using a proprietary method, Forza PTC spacers combine PEEK and...
Research on K2M’s Ravine lateral access system is to be presented at the SpineWeek 2016 Annual Meeting (May 16-20, Marina Bay Sands, Singapore). "The Ravine lateral access system allows for a lateral approach to lumbar fusion, and the dual flat...
The International Society for the Advancement of Spine Surgery (ISASS) has released the results of a surgical preauthorisation survey of its membership, conducted by Pierce Nunley, John Small, Kelly Frank and Marcus Stone. Nunley et al presented the results...
With the ultimate goal of fostering transparency and improving the health of patients, the Yale University Open Data Access (YODA) project has entered an agreement with SI-Bone that will enable researchers across the world to gain access to the...
Initial cases with the ProLift expandable interbody system, which restores disc height, in-situ, for minimally invasive PLIF, TLIF and oblique approaches, have been successfully completed, according to a Life Spine press release. “The biggest challenge in performing interbody fusions is...
NSpine is surveying female patients to investigate the effects of anterior spinal surgery with regards to scars, sexual function and relationships as part of a pilot study. The group is also looking at the prevalence of sexual dysfunction in...
The first surgeries using Safe Orthpaedics’ new SteriSpineCC range for cervical vertebrae surgeries have gone ahead successfully. Designed for single use, the SteriSpineCC kit is designed for ease of use, with its sterile instrumentation pre-mounted on the implant, aiming to...
One hundred spinal surgeries have successfully been performed with MedTech’s Rosa Spine robotic-assistive device for minimally-invasive surgery of the spine. Surgeries using Rosa Spine have been performed by: -              Michel Lefranc, a neurosurgeon at Amiens-Picardy University Hospital (France) -              Michael Winking at...
Camber Spine Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Enza zero profile anterior interbody fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation.  This clearance marks...
TranS1 has announced that its axial lumbar interbody fusion (AxiaLIF) procedure has been shown to provide estimated savings of US$3,500 compared to transforaminal lumber interbody fusion (TLIF), according to an economic analysis published in the Journal of Managed Care...
EOS imaging has sold a 10th EOS system to the Shriners Hospitals for Children Network in the United States, to be installed in Los Angeles. This is the 11th EOS system installed globally in the Shriners Network. In 2011, the...
SpinalCyte has been issued US Patent number 9,320,776, "Methods And Compositions For Repair Of Cartilage Using An In Vivo Bioreactor." The technology described in the patent involves a device which is a resorbable and biodegradable structure that can be permeable...
CoreLink has launched the Entasis sacroiliac joint fusion system in the USA. The system is designed to deliver autograft in an innovative way, and promote compression across the joint. Featuring circumferential helical graft windows, Entasis is designed to self-harvest bone graft...
Spineology has announced the full US market release of its Palisade pedicular fixation system. The Palisade pedicular fixation system is designed to minimise surgical invasiveness and enhance efficiency. The integrated break-off screw extensions and quick start screw are designed to...
SpineGuard is to launch its new PediGuard Threaded device commercially during the 2016 SpineWeek meeting in Singapore. According to a company release, this launch follows successful clinical evaluations performed by seven surgical teams in Europe and Asia. “This novel three-in-one...
The first US surgical operation using the Rosa Spine system (MedTech) has been performed at Miami Valley Hospital (Dayton, USA). Miami Valley Hospital was the first US site to acquire Rosa Spine, following US Food and Drug Administration (FDA) clearance...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the two-level thoraco-lumbar components of the Revolution spinal system from Intelligent Implant Systems. Revolution is intended to simplify single and two-level thoraco-lumbar fusions by providing a sophisticated novel...
The patented AsTris 1.0 spine simulator (BioTras) has been launched at the 18th annual American Society of Interventional Pain Physicians (ASIPP) conference. The product is designed to help doctors get training experience without the need to practice on a...
Winner of the Sanford J Larson Award, Gurpreet Surinder Gandhoke presented his research, Incidence of Position Related Neuropraxia in 4,489 Consecutive Patients Undergoing Spine Surgery. Role of SSEP Monitoring? during the 2016 American Association of Neurological Surgeons (AANS) Annual...
Winner of the Brian D Silber Award, Ganesh Mani Shankar, presented his research, BRAF Alteration Status and the Histone H3F3A Gene K27M Mutation Segregate Spinal Cord Astrocytoma Histology, during the 2016 American Association of Neurological Surgeons (AANS) Annual Scientific...
Interspinous process fixation devices are increasingly being used as minimally invasive alternatives for the management of spinal stenosis and for pedicle screw constructs in patients undergoing decompression and fusion. Spinal News International reviews the use of the ZIP ULTRA™,...
For more than a decade, PEEK-OPTIMA Natural, the first medical-grade unfilled PEEK from Invibio Biomaterial Solutions, has been used in spinal fusion surgeries, predominantly in the form of loadbearing cages. Spinal News International explores the potential of Invibio’s PEEK-OPTIMA®...
Highlights:-Fusion of multiple lumbar segments associated with sacroiliac joint pain - Motion trumps fusion at NASS debate - Chris Bono: Q&A - Investigating sacroiliac joint fusion - Profile: Marek Szpalski https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/38SpinalNews_lowres.pdf  
Highlights: -Six months in orbit reduces astronauts' cervical paraspinal muscle functional area by 17% - Treatment with more than two cages in deformity surgery improves outcomes - Artificial cervical discs: The options - Rothenfluh: Failed lumbar fusion - Robert...
Highlights: -Surgery more effective than physiotherapy in treating cervical radiculopathy -One third of adult spinal deformity patients experience implant-related complications -Jay M Zampini: Gunshot injuries -Peter Whang: The sacroiliac joint -Profile: Hyun Bae https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/36-Spinal-News_low-res.pdf  
Highlights: -Cervical disk athroplasty proponents buoyed by long-term data -Kiva system non-inferior to balloon kyphoplasty for vertebral compression fracture treatment -Feature: Robotic surgery -Akif Albayrak: Scoliosis photography -Profile: Michael Fehlings https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/35-Spinal-News_low-res-2.pdf
Highlights: -Surgical and non-surgical spinal stenosis treatment outcomes similar after eight years -Non-operative treatment of adult spinal deformity does not improve disease state or physical function -Kenneth Hansraj: Smartphone neck -Michael Kapsokavathis: Neuromonitoring -Profile: Heidi Prather https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/34-Spinal-News_LR.pdf
Highlights: -Liquid nitrogen-treated tumour tissue enhances anti-tumour immunity -Cost of implants is a barrier to spinal deformity surgery in low-income countries -Steven R Garfin: The sacroiliac joint -Marios Papadopoulos: Intraspinal pressure -Profile: William C Watters https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/33-Spinal-News-EU_low-res.pdf
Highlights: -Preoperative opioid use associated with worse patient-reported outcomes -Tantalum porous implant is a good alternative to plate and autograft in ACDF -Ibrahim Gundogdu: Spinal cord injury -Nanna Rolving: Behavioural therapy -Profile: Lori Karol https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/32-Spinal-News_low-res.pdf
Highlights: -"Innovation in spinal technology is not dead" -Cervical disc replacement may have advantages over fusion for treating two-level disease -Naresh Kumar: Salvaged blood -Markus Melloh: SedSign https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/31-Spinal-News-International_low-res.pdf
Highlights: -Disc degeneration in asymptomatic patients increases risk of low back pain -Intermittent hypoxia could be a powerful therapy for spinal cord therapy -Sport injuries -Profile: Frank Schwab https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/30-Spinal-News-International.pdf
Highlights: -Mismatch between pelvic incidence and lumbar lordosis may signal need for surgery -Riluzole: A promising neuroprotective approach for acute spinal cord injury -The Vapour trial -Profile: Philip Sell. https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/29-Spinal-News_USA.pdf  
Highlights: -rhBMP-2 has little or no clinical benefit over bone graft -Pre-emptive pain management could reduce postoperative pain -Magnetic growth rodes could potentially avoid spinal trauma by Kenneth MC Cheung -Profile: Steven D Glassman https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/28-Spinal-News_Low-res.pdf
Highlights: Patient satisfaction does not mean good efficacy; Peroperative neck pain predicts clinical benefit from cervical disc arthroplasty; Fusion is not always the best option for low back pain; Profile - Jack Zigler https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/Spinal-News-27-lowres.pdf
Highlights: -Spinal deformity affects physical function as much as cancer -Epidurial steroidal injections may increase the risk of vertebral fractures -How to manage iatrogenic flat back syndrome -Profile: Hee Kit Wong https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/26-Spinal-News.pdf  
Highlights: -Doubt cast on “gold standard” stand-alone autograft fusion -Perform spinal decompression surgery within first 72 hours -The prevention and management of surgical site infections -Profile: Michael Heggeness https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/25Spinal-News.pdf
Highlights: -Low awareness of nutritional tool in spinal cord injury centres -Low-cost Indian implants are a "safe and viable" option -Managing complications after spine surgery for adolescent idiopathic scoliosis -Profile: Christopher Shaffrey https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/24-Spinal-News-.pdf
Highlights: -Do mental health problems prevent improvement after spinal surgery? -Pedicle screw constructs may enable an earlier return to sports -Interview with Richard Kaul, founder of The Spine Africa Project -Profile: Cieran Bolger https://o6xux43a6gs4eidym2svvhon-wpengine.netdna-ssl.com/wp-content/uploads/sites/11/2016/05/23-Spinal-News-Low-res.pdf
  Highlights: -Positive signs for gene therapy in slowing the course of disc degeneration -No consensus among spinal surgeons on tests for predicting success of spinal fusion surgery for chronic low back pain -Is there a role for vertebral augmentation in...
Highlights: -Call for independent review after heavy criticism of Infuse Bone Graft studies -Acidic fibroblast growth factor is "safe and feasible" in patients with spinal cord injuries -Jacob Buchowski and Vishal Sarwahi are Whitecloud Award Winners 2011 for best clinical...
Neurological injury, pseudoarthrosis and progressive deformity are just some of the risks associated with the surgical management of high grade spondylolisthesis in young patients. A presentation chronicling fourteen years of experience treating the condition with a progressive reduction technique...
Orthopaedic spine surgeon Gunnar BJ Andersson, has taken the position of chairman of the Board of Directors of International Advocates for Spine Patients (IASP), sister organisation and patient advocacy arm of the International Society for the Advancement of Spine...
One of the most exciting areas of technology for spine is probably 3D printing which allows for the creation of virtually anything that can be designed or imaged on a computer. Initially developed in 1984, and recently applied to...
Christopher Bono (Brigham and Women’s Hospital, Boston, USA) has been appointed as North American Spine Society (NASS) president for 2015-16. He talks to Spinal News International about his involvement in the society’s ongoing projects, collaborations with other societies, and...
SI-Bone’s iFuse has now been used in over 20,000 procedures worldwide by more than 1,100 surgeons since its initial launch in early 2009. According to a company release, iFuse procedure growth has been driven most recently by the extensive body...
Mazor Robotics has installed a Renaissance guidance system at Mercy Hospital in Miami, USA. Mercy Hospital is the sixth Hospital Corporation of America (HCA)-affiliated facility to purchase a Renaissance system, and the second hospital in Miami-Dade County to receive...
Spinal Elements has been granted its 50th US patent by the United States Patent and Trademark Office (USPTO). Spinal Elements’ US patent portfolio encompasses a range of inventions in spinal fusion and motion preservation technologies. It includes interbody devices, pedicle...
RTI Surgical has launched of the Release Laminoplasty Fixation System. The system is designed to provide an efficient, streamlined surgical experience, allowing for central spinal cord decompression from C3 to T3 in laminoplasty procedures. The system consists of plates and...
The Chinese Patent Office has granted a patent to Pinnacle Spine Group for its InFill fusion technology. According to a press release, the Chinese Patent Office is in the process of issuing Chinese Patent Application No. 201180020517, titled “Intervertebral Implants...
NuVasive has launched five new surgical solutions at the 84th American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, being held April 30 to May 4, 2016 in Chicago, USA. The products include: AttraX Putty biotextured bone graft, a synthetic...
Seven-year follow-up data for the two-level application of the Prestige LP cervical disc (Medtronic) has shown favourable clinical outcomes and patient satisfaction for the artificial disc over two-level anterior cervical discectomy and fusion (ACDF). The data was presented at the...
The US Food and Drug Adminstration (FDA) has approved the UNiD cervical rod for spinal surgery, when secured by their PASS OCT posterior cervical stabilisation system. Immediately following the FDA clearance, Medicrea expanded their personalised UNiD technology and services to...
Lattice Biologics is to launch three new products using its patent-pending matrix-assisted regeneration (MAR) platform; MarBrane and MarGraft and MarCell. "With the advent of the cell viability biomarkers that Lattice Biologics is developing and implementing in their tissue recovery process,...
InVivo Therapeutics has announced that the sixth-implanted patient in the INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic American Spinal Injury Association Impairment Scale (AIS) A...
Genesys Spine’s Binary anterior cervical plating system has been awarded the Iron A’ Design Award in the category of Scientific Instruments, Medical Devices and Research Equipment Design by the grand jury panel of the A’ Design Award & Competition,...
SpinalCyte has been issued a Canadian patent for their technology, focused on regrowth of the spinal disc nucleus using human dermal fibroblasts. The technology described in the patent involves incorporating a matrix constructed of a synthetic polymer, a natural hydrogel,...
Underlining injuries associated with low back pain are often enhanced by psychological and social stressors, write the authors of a perspective published online by the Medical Journal of Australia. Leigh Atkinson, from Wesley Pain and Spine Centre in Brisbane, Australia,...
Stryker’s Spine division has introduced the Tritanium posterior lumbar (PL) cage, a 3D-printed intervertebral body fusion device designed to aid in lumbar spinal fixation for patients with degenerative disc disease, at the 2016 American Association of Neurological Surgeons Annual...
Titan Spine has appointed of Ragan E Cheney as vice president of the General Counsel. Cheney’s main responsibility will be to protect Titan Spine’s legal interests and, importantly, to ensure that the company’s intellectual property portfolio and proprietary scientific...
Wenzel Spine has announced the full commercial availability of the VariLift-LX system throughout the USA. VariLift-LX represents the next generation of Wenzel Spine’s expandable stand-alone interbody fusion devices. The zero-profile VariLift-LX system is designed to provide a broader portfolio of...
Domagoj Coric, a neurological spinal surgeon from Charlotte, USA, has become the newest member of the International Society for the Advancement of Spine Surgery (ISASS) Board of Directors. “I am excited and grateful for the opportunity to serve on the...
Psychological disorders, such as depression and anxiety, have been independently associated with higher all-cause 30-day readmission rates after elective spine surgery, in research presented at the 2016 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting. Winning the Robert Florin Resident...
Abbott is set to acquire St Jude Medical, expanding its portfolio to cover cardiovascular markets such as atrial fibrillation, structural heart and heart failure as well as neuromodulation. The combined company will thus produce devices across cardiovascular, diabetes, vision...
The treatment of many common spinal conditions by procedures designed to preserve motion or by the more conventional fusion was the subject of a series of debates at the 30th Annual Meeting of the North American Spine Society (NASS;...
William Tally (Athens Orthopedic Clinic, Greece) has performed the first spinal surgery using a new stem cell technology aimed at offering a long term solution to the degeneration of the spine. Using a product from Vivex Biomedical located in Marietta,...
People with scoliosis are now closer to a genetic explanation for their condition. According to a report, an overactive gene called ladybird homeobox 1 (LBX1) is the start of a genetic chain reaction that causes the spine to grow...
SpinalCyte has announced the final results of its phase two animal studies for transplantation of human dermal fibroblasts (HDFs) for intervertebral disc degeneration. Previously reported was a significant improvement in disc height. This final report builds on those findings with optimal dosage,...
Ortho Kinematics (OKI) has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”. Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialise in the United...
Life Spine has announced that the first clinical cases of the Gruve anterior cervical plate system have been performed. James J Lynch, founder of SpineNevada (Reno, USA), says, “The locking mechanisms allow the screws to hyper angulate to accommodate varying...
Amedica has agreed a partnership with Shandong Weigao Orthopedic Device Company, a subsidiary of Shandong Weigao Group Medical Polymer Company, a medical device company in China specialising in the research and development and the production and sale of spinal,...
Over 850 spine surgeons, scientists, researchers, and exhibitors from more than 40 countries attended the International Society for the Advancement of Spine Surgery (ISASS) 16th annual meeting (April 6-8, Las Vegas, USA). Over 530 abstracts were submitted spanning all aspects...
Two-year results from SIFI (Sacroiliac Joint Fusion with iFuse Implant System)—a prospective multicentre clinical trial of SI joint fusion—have been published in The International Journal of Spine Surgery. The trial included 172 subjects at 26 US centres, and was authored...
  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 during a pilot study published in International Orthopaedics. The study authors hope...

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One of the largest studies ever performed addressing subchondral bone marrow lesions, or “Modic changes” of the spine visible on magnetic resonance imaging (MRI), has found a clear association between the lesions and disc degeneration, as well as both...

Marek Szpalski

Inspired by Alexander Fleming, Marek Szpalski wanted to become a medical researcher. After becoming disillusioned with a life in the laboratory, he embarked on a career in orthopaedic surgery, specialising in spinal surgery. Upon achieving his medical degree in...
Recent literature has associated posterior-only approaches to the treatment of cervical spondylotic myelopathy with increased mortality. According to a paper presented at the 2016 meeting of the International Society for the Advancement of Spinal Surgery (ISASS: 6-8 April, Las...
Medtronic has claimed that a recent article published by the Minneapolis Star Tribune (Minneapolis, USA)—criticising the company’s handling of data related to its Infuse bone graft (rhBMP-2)—makes false claims and excludes key facts regarding the retrospective chart review (RCR)...
SpineSource has launched the L-Varlock lumbar cage in the USA. According to a company release, the L-Varlock is the only expandable interbody that can adjust in situ from 0 to 24 degrees of lordotic angle, and up to 7mm...
Australian regulatory authorities have approved Safe Orthopaedics’ SteriSpine ranges, which are to be distributed in Australia and New Zealand, following a distribution agreement with SSJ Health. Pierre Dumouchel, interim chief executive officer of Safe Orthopaedics, says, “This approval is a...
NuVasive a  has  launched the Integrated Global Alignment (iGA) platform in the UK at BritSpine (Nottingham, UK). Paul Kosters, NuVasive’s vice president of Europe, Middle East and Africa, says, "We are pleased to participate at BritSpine 2016…we are eager to...
Interventional Spine has launched a new line of products, which were showcased at this year’s International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting in Las Vegas, USA. The new products include recent size additions to the Opticage...
Premia Spine has launched the ProMIS fixation system with its Advanced MIS screw placement at the 2016 International Society for the Advancement of Spine Surgery Meeting (ISASS; Las Vegas, USA).   Steven DeLuca, from the Orthopedic Institute of Pennsylvania (Pennsylvania, USA)...
Previously injured axons (red) can grow through a dense astrocyte scar (green) in the presence of molecules that stimulate growth (blue). According to a new mouse study, astrocyte scars—long considered responsible for blocking neuronal regrowth across the level of spinal...
RTI Surgical has launched new deformity instrumentation for its Streamline TL spinal fixation system for complex adult deformities or curvatures. The instruments were designed with a focus on versatility, ease-of-use and surgeon comfort, according to a company release. The Streamline...
Implanet has been granted US Food and Drug Administration 510k clearance and CE marking  in Europe to market its new Jazz Lock implant. Jazz Lock is the first of a range of band products designed for degenerative spine disorder surgery....
The first procedure using the FLXfit expandable cage from Expanding Orthopedics (EOI) has been performed by William D Smith at the University Medical Center in Las Vegas, USA. Smith, director of Performance Improvement for the Western Regional Center for Brain...
Medtech has made its first US Rosa Spine sale to Miami Valley Hospital, Dayton, USA. The hospital is a 970-bed medical facility, which received the Healthgrades “America’s 100 Best Hospitals’ Award” in 2016, and has received the Healthgrades “Distinguished Hospital...
DSM Biomedical has announced that its medical-grade Dyneema Purity fibres fully meet the requirements of ASTM International’s revised standard F2848-16 for medical-grade ultra-high-molecular-weight polyethylene (UHMWPE) yarns. The standard establishes clear requirements for medical-grade UHMWPE yarns. Recognised by the US Food...
Until now, the role of galectins and their docking sites in osteoarthritis was largely unknown. In a study recently published in the Journal of Immunology, MedUni Vienna researchers have managed to identify the function of galectin-1 for the first...
TranS1 has named Brandon Arthurs vice president of research and development. In this role, Arthurs, a certified professional engineer, will be responsible for leading collaborations with surgeons and entrepreneurs to bring new medical products to market. According to a...
The US Food and Drug Administration (FDA) has approved spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging from EOS imaging. This follows CE marking, which was reported in March 2016. The spineEOS online...
K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) for expanded indications of its Mesa Mini and Denali Mini spinal systems. The Mesa Mini and Denali Mini spinal systems function as adjuncts to fusion, providing stabilisation...
The newly patented AsTris 1.0, designed to help doctors practice for spinal injections, is to make its debut Dallas, USA, at the 2016 American Society of Interventional Pain Physicians (ASIPP) conference, April 14-16 at the Hyatt Regency. For pain management...
The Spine Hospital of Louisiana at The NeuroMedical Center, Baton Rouge, USA, has become the first hospital in the USA to install the Ultimax-i FPD multipurpose system from Toshiba America Medical Systems. This X-ray system is designed to provide a wide...
The first four patients have been enrolled in the expanded Evolusion (EVSI) clinical study. This prospective, 40-site, 250-patient trial will evaluate long-term fusion and pain reduction in patients treated by Zyga’s SImmetry sacroiliac joint fusion device. "Minimally invasive sacroiliac joint...
Stryker’s Spine division has acquired use of the SafeWire product portfolio, including the Y-Wire guidewire and Tiger Jamshidi Needle Family for use in minimally invasive spine surgery. Acquired from SafeWire, the Y-wire features a patented feature that is designed to...
Medovex has entered into an international distribution agreement with Innosurge, a supplier of orthopaedic surgery equipment. The agreement covers the distribution of its DenerveXSystem throughout Scandinavia, including Denmark, Sweden, Norway and Finland.   Innosurge is expected to provide sales, marketing and...
According to a company release, the OrtoWell distractor instrument for spinal surgery from OrtoWay can now be used by surgeons in connection with spinal tumour removal or trauma.   Following tests on animals and cadavers, it was shown that the device...
X-Spine—a subsidiary of Xtant Medical—has been granted clearance from the US Food and Drug Administration for the Xspan laminoplasty fixation system. The Xspan device is intended for use in the lower cervical and upper thoracic spine (C3-T3). "We are very...
Renovis Surgical technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SC, a porous titanium cervical interbody fusion system. Tesera SC features a three-screw design and a locking cover plate to prevent...
Bone Therapeutics has announced the 12-month efficacy results from the first cohort of seven patients treated with Preob in its phase IIA severe osteoporosis trial. These initial data demonstrate positive effects on pain and osteoporosis blood markers associated with...
Five-year clinical results have shown cervical total disc replacement to offer a superior alternative to anterior discectomy and fusion for treatment of two-level symptomatic degenerative disc disease. The data have been published by the Journal of Neurosurgery: Spine. Based on...
Older Americans are increasingly active, and this lifestyle shift has contributed to the rise in average age of a person experiencing a spinal cord injury. The changing demographic calls for a better understanding of how aging impacts recovery and...
Sacroiliac joint fusion surgery has grown in popularity over the past five years. Whilst procedure rates are still relatively low, many physicians are convinced of the surgery’s benefit for the treatment of pain generated in the sacroiliac joint. With...
SpinalCyte has announced the preliminary results of its Phase II Animal Studies for Spinal Disc Height Improvement. The study began in 2014, and is led by Howard An, the Morton International endowed chair professor of Orthopedic Surgery and  director of...
A seventh patient has been enrolled into the INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic American Spinal Injury Association Impairment Scale (AIS) A Spinal Cord...
Writing in the March 28 issue of Nature Medicine, researchers at University of California, San Diego School of Medicine and Veterans Affairs San Diego Healthcare System (San Diego, USA) with colleagues in Japan and Wisconsin, USA, report that they have...
Stimwave has begun to market the StimQ peripheral nerve stimulator (PNS) system for the relief of severe intractable chronic pain of peripheral origin. The system is designed to provide relief to peripheral nerves with an implantable device that can be...
The number of segments involved in lumbar and lumbosacral procedures has been shown to affect the incidence of sacroiliac joint pain, in a study published online in Spine, confirming the symptom as a potential cause of low back pain...
Amedica has announced its first fabrication of complex, three-dimensional structures by a 3D printing process called robotic deposition, or robocasting. The final products have been examined under scanning electron microscopy to confirm the integrity and validity of the 3D...
According to a study published in The Spine Journal, the Spine Adverse Events Severity (SAVES) system—a recording instrument created to comprehensively record the mobility and mortality associated with complex spinal surgery—can be generalised to non-Canadian populations of all ages....
The use of stem cells in spinal surgery was a focus of discussion at both the Brussels International Spine Symposium (BISS; 20-21 November, Brussels, Belgium), and the Annual Meeting of the North American Spine Society (NASS; 14-17 October, Chicago,...
Blue Cross Blue Shield (BCBS) of Michigan, USA, the largest commercial insurer in the state of Michigan, has issued a positive medical policy statement for minimally invasive sacroiliac joint fusion. BCBS of Michigan becomes the first of the 36 BCBS...
EOS imaging has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China. The EOS system can now be marketed in 51 countries. The EOS system is in clinical use in several markets in...
The US Food and Drug Administration has announced a proposal to ban most powdered gloves in the USA. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care...
The US Food and Drug Administration (FDA) has proposed a rule change with regard to posterior cervical screw systems.   The FDA wishes to classify these systems  as class II, which reflects ‘special controls’. Premarket notification will still be required to...
SpineGuard has announced a national stocking distribution agreement with OrthoPediatrics for the exclusive commercialisation of its PediGuard probes in US paediatric institutions. “We are delighted to partner with OrthoPediatrics for the distribution of our smart drilling devices. I have been...
Jeff Dunkel, Titan Spine vice president for Strategic Partnering, has been appointed to the Executive Operations Committee of the Medical Device Epidemiology Network Initiative (MDEpiNet). The initiative is a collaborative program of the US Food and Drug Administration (FDA)’s Center...
Orthofix has appointed Michael E Paolucci to its Board of Directors and its Compensation Committee. A human resource executive, Paolucci has more than 20 years of global experience working with boards of directors and C-level executives to improve organisational capabilities...
Amendia has launched its new corpectomy device, the Incorporate, commercially in the USA. The device is intended to provide surgeons with a safe and versatile vertebral body replacement option to replace a collapsed, damaged or unstable vertebral body. The Incorporate...
Precision Spine has announced the launch of its Reform modular pedicle screw system and Reform HA-coated pedicle screw system. The Reform system features a cobalt chrome tulip with a proximal tapered triple lead thread, which is designed to help increase...
Implanet has started a prospective and multicentre clinical study, designed to document the outcomes of the Jazz band in adult degenerative and adult deformity indications. Implanet has partnered with TFS International, a professional contract research organisation, to help promote a...
A new study has shown that vibrating the spine may reveal more than magnetic resonance imaging when it comes to treating back pain. Teaming with the University of South Denmark (Denmark) to study the lumbar spine of twins, Greg...
  BioTras has received a US patent for AsTris 1.0 (US Patent No. 9,275,556) medical training simulator that for training in interventional pain management. The patent was approved on March 1, 2016. Dallas-based pain management doctors John East and Brandon Knutson...
Medicrea’s UNiD lab services have now been used in more than 500 surgeries worldwide. The services include a real-time support team to surgeons in the pre-operative planning of spinal procedures, order fulfillment for the company’s UNiD patient-specific spinal rod...
Rainbow Medical is to collaborate with Medos International Sarl, part of the DePuy Synthes Companies of Johnson & Johnson. The collaboration will be focused on the development of a novel therapy for treating degenerative disc disease. This collaboration seeks to...
Nanovis has received a grant award from the National Institute on Aging, part of the US National Institutes of Health (NIH). To date, Nanovis’ spinal nanotechnology platform and soft tissue regeneration nanotechnology platform have received eight competitive, peer-reviewed grants...
Medtech has sold its first Rosa Spine robotic surgery system in the USA to Miami Valley Hospital, Dayton, USA. Miami Valley Hospital is a 970-bed medical facility. It is a recipient of the Healthgrades “America’s 100 Best Hospitals’ Award in...
Together, the American Academy of Physical Medicine and Rehabilitation (AAPM&R) and the American Association of Neurological Surgeons (AANS) are creating a Spine Patient Registry, which will support the collection and submission of quality data specific to spine patients and...