Spine Features & News
Robin Young • Mon, June 17th, 2013
YODA Committee and other experts from government and academia / Courtesy of Centers for Outcomes Research & Evaluation, Yale University
What a pleasure to read a well done study. Give it up for the Yalies and the Oregonians. Stark contrast to Carragee’s hatchet job. What did they conclude about Infuse? It works in certain patients and certain conditions and not in others. Retrograde ejaculation? Non issue. Cancer risk? Exceedingly small. To read the details, go here.
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Medtronic, Inc. has received CE Mark for a device used to treat patients with a severe form of spinal curvature to allow them to potentially stand up straighter without pain. On June 13, 2013, the company announced the launch of the ReDux Plier calling it the “first specialty-designed surgical instrument” in the spinal orthopedic industry…
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Researchers from Henry Ford Health System have found that a higher number of lumbar epidural steroid injections (LESI) is associated with an increased risk of vertebral fractures. The authors indicate that LESIs may lead to increased bone fragility over time, and while injection therapy is useful in some cases, it should be approached cautiously for…
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Spinal Elements, Inc. has announced that they have licensed a portfolio of patents essential for accessing the lumbar spine from a lateral approach and placing implants from that approach. The lateral approach to the spine provides the potential for less disruptive, minimally invasive surgical (MIS) access techniques to address numerous spinal pathologies. Spinal Elements plans…
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Robin Young • Tue, June 11th, 2013
Source: Wikimedia Commons and Paul Clarke
Physicians are at the front lines of healthcare change. How are they doing? Not so good, in fact. Deloitte released the results of its annual survey of 20,472 physicians. By and large, U.S. docs are pessimistic about their future and the outlook for healthcare. But there were some bright spots. Here is a summary.
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Small persons with large back pain, take heart. K2M, Inc. is coming to the rescue. The company has announced the launch of the MESA Small Stature Spinal System in the Australian, New Zealand, and European spine markets. This is the company’s first posterior spinal fixation product available for small stature patients. It boasts a 4.5…
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This is the story of an incubator. The company, Minnesota Medical Physics, occupies one of a row of identical office spaces in a business center located in Edina, Minnesota. CEO Ali Jaafar and Principal Scientist Victor Chornenky, Ph.D., started the company in 2001 to develop “Innovative Solutions to Unmet Medical Needs.” Educated as a physicist,…
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NuVasive, Inc. launched its Maximum Access Surgery Posterior Lumbar Interbody Fusion (MAS® PLIF) procedure on May 31, 2013. After an initial limited launch around the U.S., the procedure is now available for patients and surgeons in Australia, Switzerland, Italy, Germany, and the United Kingdom.
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After years of off-label use, the FDA’s orthopedic panel finally recommended on May 22, 2013, that the FDA acknowledge what practioners are already doing and officially downclassify thoracolumbar pedicle screw spinal systems. The devices are intended to treat degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1, or…
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Robin Young • Thu, May 30th, 2013
Image created by RRY Publications, LLC
There are lies. There are damn lies. Then there is the stuff that Blue Cross Blue Shield of North Carolina puts on its web site. One neurosurgeon finally had enough of the flat earth society that is BCBSNC. And he wrote a remarkable letter.
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Lanx, Inc. says it is launching the first modular anchored interbody device for lateral fusion. The Timberline MPF Lateral Modular Plate Fixation System enhances the Timberline system platform, which has seen “strong” adoption since its launch last year.
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Big news from Japan…Researchers from the RIKEN Center for Integrative Medical Sciences have identified the first gene to be associated with adolescent idiopathic scoliosis (AIS) across Asian and Caucasian populations. The gene is involved in the growth and development of the spine during childhood. Dr. Ikuyo Kou and Dr. Shiro Ikegawa have just published their…
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Integra LifeSciences Corporation is presently staging the full market release of its Hollywood VI intervertebral body fusion device (IBD) system.
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Imagine the massive effort required to spend a full day presenting evidence to the FDA orthopedic panel to prove your device is safe and effective. SpinalMotion, Inc. is doubling down and going for two days in July.
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Robin Young • Fri, May 10th, 2013
Source: DHHS
Three aspects of CMS’ proposed payment system stand out to us. First orthopedics did ok, not great, but ok. Second the quality police are coming and 25% of all hospitals can expect to be penalized. And finally, the definition of “inpatient” is being tweaked. Oh, oh.
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Wenzel Spine, Inc. has launched its VariLift-C stand-alone zero-profile expandable cervical interbody fusion device in the U.S. The company received FDA clearance in January 2013.
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Medtronic Inc.’s spinal business launched several new product line additions to the company’s Vertex Select Reconstruction system at the 81st American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in New Orleans. The company also launched the MAST Aligned procedure at the meeting on April 29, 2013.
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A study of Titan Spine, LLC Endoskeleton titanium interbody cage, presented at the 13th Annual Meeting of the International Society for the Advancement of Spine Surgery, found that the device achieved rapid lumbar fusions. The study looked at 77 patients with a mean age of 46 years who underwent an ALIF procedure using the Endoskeleton…
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Robin Young • Mon, April 29th, 2013
Source: Wikimedia Commons and NASA
Orthopedic surgeons make a living with their hands. But a recent study offers data that robotic assistance can improve surgical precision significantly. Is the game changing? Will surgery in the future be as much about the robot as it is the surgeon? The data seems to say “yes.”
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Not all vertebral compression fractures (VCFs) are the same. For instance, some have different vertebral height profiles. In a peer-reviewed article published in the April edition of Techniques in Regional Anesthesia and Pain Management (Volume 16/Number 2), Benvenue Medical, Inc.’s Kiva and Blazer systems were highlighted as being “among the most innovative experimental and commercial…
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Relievant Medsystems, Inc., is a Redwood, California-based privately held medical device company pioneering the therapeutic use of basivertebral nerve ablation for treating chronic axial low back pain. The company has completed an interim review of safety results of the company’s SMART Clinical Trial which is evaluating its Intracept therapy for chronic low back pain. The…
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The Royal National Orthopaedic Hospital (RNOH), the largest musculoskeletal orthopedic hospital in the United Kingdom, and U.S.-based SpineMark Corporation, have announced a joint agreement to develop a spine research unit within RNOH called Spinal Research Stanmore (SRS). RNOH will provide administrative support and clinicians to meet the demands of industry and internal study goals including…
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Robin Young • Fri, April 19th, 2013
Hawks Cay Lagoon / Courtesy of Hawk’s Cay
Small spine meetings are so much better for physicians who want to improve their skill sets and learn about new techniques or technologies. There are a couple of very good small meetings. Antonio Castellvi’s meeting in Duck Key in a couple weeks is the best of the best. Here’s why.
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Only three surgeons in the Tampa Bay area of Florida are performing robotic spine surgery…and they’re all at the Florida Orthopaedic Institute (FOI). The surgeons are using technology from Mazor Robotics Ltd, and are seeing lower radiation exposure and higher accuracy among implant cases. Asked what led to the decision to move toward this surgery,…
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gSource, LLC is announcing a recent donation of its surgical instruments to the Foundation of Orthopedics and Complex Spine (FOCOS), an organization founded by Oheneba Boachie-Adjei, M.D., Professor of Orthopedic Surgery and Chief Scoliosis Surgeon at Hospital for Special Surgery. The donated instruments, valued at $4,380, will be provided to the FOCOS Orthopedic Hospital in…
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Family physicians are ordering too many lumbar spine MRI scans, according to a Canadian study reported March 26 by Crystal Phend, senior staff writer for MedPage Today. Only 34% of lower back scans ordered by family physicians were considered appropriate compared with 58% ordered by physicians in other specialties. Derek Emery, M.D. and his colleagues…
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A physician-driven study of 40 patients with painful osteolytic vertebra metastases who investigators treated with the Kiva VCF Treatment System by Benvenue Medical, Inc. found that all of the patients experienced a clinically relevant improvement in their pain and statistically significant functional improvement at the end of one month. According to the researchers, the group…
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Integra LifeSciences is adding a second cobalt chrome rod for its Daytona and Malibu Spinal Systems. According to the firm’s release, the new rod, called the Enhanced Strength and Stiffness rod (ESS) provides more strength and stiffness than is contained in the existing cobalt chrome rod. The company plans a controlled market release of the…
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Jeff White • Tue, March 26th, 2013
Source: Wikimedia Commons and Antonio Balestra
TranS1 and Baxano’s proposed merger is a good deal—given the circumstances. Both firms seemed to be faced with a choice between a crew cut or the guillotine. What does this deal say about these promising young spine companies and the environment for innovation generally? Read on.
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How much do spinal implants—the screws, plates and cages used in spinal surgery—cost a hospital? A study, presented at the recent AAOS conference and reported on by Nancy Walsh, staff writer for MedPage Today, found wide differences in what hospitals paid for similar devices. In their study Samuel Bederman, M.D., Ph.D., and Sohrab Pahlavan, M.D.,…
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