Becker's Spine Review

41 Sign up for Becker's Orthopedic, Spine Business & Pain Management E-Weeklies at www.BeckersOrthopedicandSpine.com or call (800) 417-2035 ducting trials, along with InVivo Therapeutics. Instead of focusing on regeneration exclusively, InVivo concentrates on neuroprotection and its products are intended to protect the spinal cord after primary injury by mitigating the bleeding, inflammation and further cell death after SCI while promoting neuroplasticity. Data on InVivo's technology was first published in 2002 and has since demonstrated success in prompting functional recovery from SCI in sev- eral models, including rodent and non-human primates. In April 2013 the FDA granted InVivo its investigational device exemption human trail approval for a 15-month study on its biopolymer scaffold product, and the company received per- mission to update the trial in January 2014. Robotic navigation. Robotic navigation and guidance are gaining popularity among several medical specialties. Although some contention remains among spine surgeons, an increasing number are looking into the potential benefits of using robotic technology. Mazor Robotics is cur- rently the only company producing a mechanical guidance system for the spine that has FDA clear- ance and CE marking. The company's Renaissance system has been used in thousands of procedures worldwide for increased precision in minimally invasive surgical cases as well as complex spinal deformities. The technology allows surgeons to plan the operation in a virtual three-dimensional environment to create a surgical blueprint for each individual patient. Studies show the technology may be able to improve accuracy and reduce radiation exposure when compared with fluoroscopy during spinal cases. A study published in early 2014 shows using ro- botic guidance shortened spinal procedure time and decreased radiation exposure by 74 percent when compared with fluoroscopy and 50 percent when compared with navigated augmentation. In a January 2014 interview with Becker's Spine Review, Mazor Senior Vice President Christo- pher Prentice mentioned that while verification on screw placement often happens post-action, he hopes the technology will evolve to the point where surgeons can view their progress in real time and execute the surgical plan while instanta- neously knowing they are still "on plan." Anterior vertebral body tethering. For adolescent patients with scoliosis, anterior vertebral body tethering potentially represents a huge leap for- ward in fusionless treatment. In the right patient, the procedure can prevent the convex side of sco- liosis from growing until the concave side catches up, allowing the spine to correct without undergo- ing fusion. The surgeon performs the procedure thorascopically through three small incisions and runs the tether through the screw heads to correct the curve; the tether can be adjusted and loosened if necessary to prevent over-correction. Only a few centers in the world have this proce- dure, but Amir Samdani, MD, Chief of Surgery at Shriners Hospital for Children — Philadel- phia — and one of the surgeons performing this procedure — expects more spine centers to adopt the procedure in the future. Dr. Samdani has per- formed more than 70 anterior vertebral tethering procedures and of those studied, more than 90 percent avoided fusion. Genetic testing. The ability to better predict how adolescent idiopathic scoliosis will develop presents a big opportunity to improve care and lower costs for patients. ScoliScore developed the AIS prognostic test to help physicians determine which patients with mild AIS are likely to develop severe scoliosis with 99 percent accuracy. The saliva-based test collects DNA from patients to measure DNA markers for progressive or pro- tective genes that impact the spinal curve. The re- sults are then converted into a numbered scale to measure the patient's likelihood to develop severe scoliosis. This test has the potential to eliminate routine physician visits and multiple imaging tests traditionally used to monitor scoliosis pro- gression and can help physicians and patients de- velop the appropriate treatment plan. Genetic testing may also have a place in disc de- generation treatment in the future, but testing is still in the basic science stages. Spinal fusion. The spinal fusion field has de- veloped significantly over the years, and despite competition from motion preserving and non- fusion devices, it remains among the most profit- able sectors in spine. Advancements to promote fusion in the biologic realm are exciting, but non- fusion still occurs in some patients and the imag- ing to track progress is expensive. Intellirod Spine has developed an implantable wireless sensor technology to assess spinal fusion while minimizing costs associated with CT scans. The system is more quantifiable than traditional imaging and can identify complete healing sooner without additional patient exposure to radiation. Other technology is gaining recognition around the country; last year, a Chicago Innovation Award was given to Life Spine for its AILERON Expandable Posterior Fusion System, which has an in-situ expandable core that offers patient matched expansion to custom fit the procedure. Finally the InFill Direct Lateral Fusion system including the InFill Graft Delivery System from Pinnacle Spine Group is emerging as a solution for skeletally mature patients. The system is de- signed for use with autogenous bone graft to facilitate fusion. It is filled with graft material in situ, allowing for complete contact between the vertebral bodies and graft material. In 2013 an in- dependent study confirmed surgeons can achieve up to 94 percent more graft material between the vertebral bodies using the InFill system. Spinal cord stimulation. In March 2013 the FDA approved Medtronic's SureScan, a spinal cord stimulator compatible with MRI. The device was used with the first patients in the United States last year to treat chronic back and leg pain. Pa- tients are able to undergo MRI without having to first remove the SCS, which represents an impor- tant leap forward in the technology. SureScan also offers protection against patient injury and device damage with a shielded Vectris lead to reduce the risk of thermal tissue damage. Additional protective technology, such as filtered feedthroughs, protects the neurostimulators by preventing RF energy from the lead outside of the stimulator. The device was tested and modeled across more than 10,000 different patient scenarios and 100 million simulated scans for patient safety. Interbody fixation at L5/S1. There are currently a few techniques for less invasive interbody fixa- tion at L5/S1, including AxiaLIF and Oblique Lat- eral Lumbar Interbody Fusion. Baxano Surgical's Axial Lumbar Interbody Fusion is a minimally invasive alternative approach to traditional fu- sion procedures. Originally developed by TranS1 — which acquired Baxano last year — AxiaLIF received a Category I CPT code in 2013. The tech- nology was originally developed more than a de- cade ago and was performed on more than 14,000 patients before receiving a CPT code, but still not all U.S. health plans cover the procedure. Amendia's Zeus OLLIF device is constructed of PEEK and includes aggressive teeth to prevent im- plant migration. The patented cannulated design helps to safely guide the implant past the nerve root and the instrument set is designed to mini- mize operating time. Scott Spann, MD, founder of Pantheon Spine, also developed the lateral access device Epiphany to access L5/S1 for patients with advanced degenerative disc disease. Imaging technology. Spinal imaging technology made great leaps forward in the past decade and continues to strive toward better imaging for spine patients. While several companies fall into this arena, Esaote North America's G-scan brio weight bearing MRI and NeuroLogica's BodyTom porta- ble computed tomography bring exciting develop- ments to the field. The G-scan brio utilizes second generation MRI technology with improvements in both receiver coil and XP technology for sharper images at a lower cost. Patients can receive images in a clinostatic or orthostatic position because the machine's magnet rotates from 0 to 90 degrees. NeuroLogica's BodyTom is a battery powered ma- chine that can be transported from room to room and is compatible with PACS, surgical navigation, electronic medical records and planning systems. In January 2013, Samsun Electronics acquired NeuroLogica and a year later the company an- nounced a partnership with Stryker to provide surgical navigation with the portable CT scanner. Finally, the LevelCheck tool from Johns Hopkins University/Siemens Healthcare is designed for intra- operative imaging to avoid wrong-site surgery. The technology allows surgeons to localize structures defined in preoperative three-dimensional imaging with intraoperative fluoroscopy and operates with- out additional tracking or navigation equipment. Sacroiliac joint fusion. Less invasive sacroiliac joint fusions are emerging as a solution for patients with lower back pain caused by the SI joint. SI- BONE's iFuse has been used in more than 10,000 procedures worldwide, a milestone announced at the beginning of 2014. The device received FDA clearance in November 2008 and two studies were published last year showing more pain relief and ©2014 SpineCraft, LLC. All rights reserved.

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