Becker's Spine Review

43 sizes to accommodate different types of screws so surgeons don't need the original screwdriver for removal. e Gordoncoptor does need the original locking cap nut and compatible wrench to remove the screw. i-FACTOR Bone Gra (Cerapedics). e i-FACTOR Bone Gra, categorized as an "at- tachment factor," is the only bone gra that uses a novel mechanism of action based on the cell binding of osteogenic precursor cells to a syn- thetic protein segment found in Type I human collagen, simply known as P-15. Cells bind to the P-15 found in i-FACTOR Bone Gra just as they would bind to the natural amino acid sequence in collagen, the primary organic com- ponent in bone. is novel mechanism of ac- tion enhances the body's natural bone healing process, resulting in safe and predictable bone formation. e P-15 technology has been ex- tensively evaluated in scientific and preclinical studies. e published clinical experience with i-FACTOR Bone Gra includes the results of the investigational device exemption study in single-level anterior cervical discectomy and fusion that demonstrated superiority to auto- gra in overall success. iFuse Implant System (SI-BONE). e iFuse Implant System is used to perform a minimally invasive sacroiliac joint fusion procedure. Sur- geons have used the technology in more than 25,000 procedures since the technology became available in 2009. ere is considerable litera- ture supporting the procedure, with more than 50 peer-reviewed publications covering clinical results, biomechanics and economics. In June, Highmark established a positive coverage poli- cy for minimally invasive sacroiliac joint fusion exclusively for iFuse. Kyphon Xpede Bone Cement (Medtronic). In March 2017, Medtronic received FDA clear- ance for the Kyphon Xpede Bone Cement for pathological fracture fixation of the sacral ver- tebral body through sacral vertebroplasty or sacroplasty. Xpede previously received FDA clearance for treatment of vertebral fractures due to osteoporosis, cancer or benign lesions. e quick-to-dough bone cement paired with the Kyphon Cement Delivery System allows cli- nicians to perform the procedure with minimal radiation exposure from up to four feet away from the patient during the injection. Lamellar 3D Titanium Technology (K2M). e Lamellar 3D Titanium Technology uses advanced 3-D printing to create structures tra- ditionally considered impractical for manufac- turing. e implants are grown through selec- tive application of a high energy laser beam on titanium powder, incorporating a porosity and surface roughness associated with bone growth activity. Mazor X (Mazor Robotics). Mazor X is a spine surgery guidance platform developed to enhance predictability in spinal procedures. e technology combines analytical tools, multiple-source data and precision guidance with optical tracking, intraoperative verifi- cation and connectivity technologies for the surgeon to perform a more precise procedure. Mazor entered into a strategic partnership with Medtronic in May 2016 to co-develop and commercialize the technology, which was launched in October 2016. Over the past year, Mazor reported significant interest in Mazor X, and Medtronic decided to accelerate invest- ment in the company. M6-C (Spinal Kinetics). e M6-C is an artifi- cial cervical disc that incorporates an artificial nucleus, made from polycarbonate urethane and a polyethylene woven fiber annulus. e M6 is designed to mimic the motion of a nat- ural disc, with the disc's nucleus and annulus allowing 6 degrees controlled range of motion. e M6 has two titanium plasma spray-coated titanium outer plates with keels to anchor the disc into the vertebral body bone. Mobi-C (Zimmer Biomet). Designed by a French surgical team, Mobi-C was first im- planted in November 2004 and eventually re- ceived FDA approval in August 2013. Mobi-C became the first cervical disc to receive FDA clearance for two-level disc replacement pro- cedures. Mobi-C is made of cobalt, chromium and molybdenum, and is designed with teeth on the top and bottom to help hold plates to the vertebra. Endoskeleton with nanoLOCK surface tech- nology (Titan Spine). Titan Spine received FDA clearance to market its Endoskeleton in- terbody fusion implants with the next genera- tion nanoLOCK surface technology in 2014. e nanoLOCK surface technology increases the amount of nano-scaled textures to up-regu- late a statistically significant greater amount of the osteogenic and angiogenic growth factors critical for fusion. In 2016, CMS created a new technology ICD-10 code for a nanotextured surface on an interbody device and the nano- LOCK was first to receive access to this code. NVM5 (NuVasive). e NVM5 platform is a set of intraoperative technologies designed for spine surgery, including multimodality monitoring of the spinal cord and nerves. e system also includes refinements such as the rod-bending technology Bendini. NVM5's mo- dalities include simulated electromyography, motor evoked potentials and computer-assisted surgery applications. Tritanium (Stryker). Tritanium PL is a poste- rior lumbar cage designed for bone in-growth and biological fixation. e implant has a mi- crostructure of cancellous bone enabled by Stryker's patent protected 3D Additive Manu- facturing process. XLIF (NuVasive). More than 350 published clinical studies support the efficacy of eXtreme Lateral Interbody Fusion over 10 years. Nu- Vasive developed the minimally invasive pro- cedures as a lateral lumbar interbody fusion, approaching the patient's spine from his or her side to avoid disrupting back muscles. Studies show XLIF is associated with less blood loss, shorter hospital stay and reduced postoperative recovery time when compared with the tradi- tional approaches to surgery. Cerapedics is an orthobiologics company focused on developing and commercializing its propri- etary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available growth factors. More information can be found at www.cerapedics.com.

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