Becker's Spine Review

39 Sign up for Becker's Orthopedic, Spine Business & Pain Management E-Weeklies at www.BeckersOrthopedicandSpine.com or call (800) 417-2035 20 Cutting-Edge Innovations in Spine 20 Cutting-Edge Innovations in Spine By Laura Miller Sponsored by: S pinal innovations and techniques have grown tremendously over the past decade, especially within the last few years. Here are 20 cutting-edge innovations in spine. Minimally invasive lateral techniques. NuVasive was among the first companies to develop a minimally invasive lateral spine surgery approach, an alternative to the traditional anterior or posterior approaches. Founded in 1999, the company is now the third largest spine device company in the United States and fourth globally with more than 90 products spanning the lumbar, thoracic and cervical spine. NuVasive's eXtreme Lateral Interbody Fusion proce- dure is the only lateral procedure now validated with 10 years of clinical experience. It has more than 140 published clinical studies supporting outcomes, re- duced blood loss, shorter operating room time and hospital stays when compared with traditional fusions. Over the past few years, several other spine com- panies have released lateral approach devices mak- ing an impact on the field today, including the VEO Lateral System from Baxano Surgical for direct vi- sualization for lateral fusion surgery. The Society of Lateral Access Surgery, supported with NuVasive funding, was created to foster research, surgeon education initiatives and peer-to-peer communi- cation advancing lateral techniques. The society participates in advocacy events, patient education and research to develop the future of lateral access technology and bring it to a broader patient base. Cervical disc replacement. Artificial disc replace- ment has been around for nearly two decades, but gained popularity recently as long-term data shows equal and better outcomes in comparison to spinal fusion. Several new cervical discs are on the market, including the Mobi-C from LDR, which has FDA approval for both one- and two-level indications. The market is expected to grow over the next sever- al years as physicians and patients look for motion sparing fusion alternatives. This is especially true as reimbursement roadblocks are removed; the Amer- ican Medical Association announced cervical disc replacement will receive a Category I CPT code be- ginning in 2015 and multi-level disc replacements will fall under the Category III CPT code. Clinical data also supports cervical disc replace- ment. Medical Director and Director of Spine Edu- cation at Cedars-Sinai in Los Angeles Hyun Bae, MD, presented 48-month safety and efficacy data for the Mobi-C cervical disc compared to ACDF at the 2013 North American Spine Society Annual Meeting. While average neck disability scores and improvement were similar among both patient groups, reoperation rate was significantly lower for Mobi-C (3 percent at one level) compared with ACDF (9.9 percent at one level). Among the first five-year data to be released was on the ProDisc II from Synthes in January 2014. The data demonstrated improvements in VAS and ODI scores at all levels, higher patient satisfaction and a low complication rate. Stem cell technology. Many companies are working on investigational trials and basic science research into stem cell technology. Stem cell technology has gathered steam over the past few years and several projects are examining their potential use for spine. In particular, adult stem cells use to enhance spinal fusions is becoming a more popular concept. Aurora Spine helped advance the use of amniotic fluid with its pluripotential cells — growth factors for spinal surgery — through its product Amniopur. Mesoblast also recently released positive outcomes from the company's 100-patient Phase 2 clinical trial using allogeneic mesenchymal stem cells to potentially repair intervertebral discs or regenerate new bone. Other companies are in phase 1 trials for cell-based technology that could have an impact on disc health and regeneration in the future. PEEK. Implantable polyetheretherketone has made significant headway over the past decade to become a common biomaterial used in spinal devices. Invibio Biomaterials Solutions introduced PEEK-OPTIMA, the first in an extremely versatile family of poly- meric biomaterials, in 1999. PEEK-OPTIMA devices provide controlled visibility through X-ray, CT and MRI technologies allowing surgeons to verify device placement postoperatively and assess the healing site. These polymers are used to manufacture several FDA-approved spinal devices. Literature supporting PEEK in cervical cases shows improved spinal align- ment and geometry, shorter hospital stays, less blood loss, fewer complications and good fusion rates. Biological treatment for spinal cord injury. Geron began the first clinical trial of a therapy derived from human embryonic stem cells in spinal cord injury patients in 2009, but shut down the trial a year later due to financial difficulties. The company, which maintained the trial was not shut down for "lack of promise" among spinal cord patients — according to an article in the New York Times — but rather be- cause the company decided to focus on experimen- tal cancer therapies. However, patients who began therapy during the trial's short period were allowed to continue and researchers will gather data which could serve as a base for future development. But Geron wasn't the only company after spinal cord injury treatment; StemCells Inc., was also con-

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