Becker's Spine Review

43 Tricare and commercial payers including Blue Cross Blue Shield plans, have approved coverage of the iFuse Implant System. In January 2017, SI-Bone rolled out a warranty program for the implant, guaranteeing the product and results with a promise to supplement or replace the implant within one year of the initial procedure if revision is required. More than 50 peer-reviewed studies have been conducted on iFuse, with positive results. FLXfit 3D Expandable TLIF Cage (Expanding Orthopedics). e FLXfit is an expandable, articulated interbody fusion device surgeons can use in conjunction with supplemental fixation in skeletally mature patients aer total or partial discectomy. e titanium cage articulates laterally and expands in height to enable larger footprint support and disc height restoration. e technology can be used with the MIS FLXfit Inserter, designed to fit through a narrow access tube and maintain a clear line of sight for visualization through the microscope. Lamellar 3D Titanium Technology (K2M). e Lamellar 3D Titanium Technology uses an advanced three-dimensional printing method to create unique structures that aren't possible with traditional manufac- turing techniques. e implants are grown through selective applica- tion of a high-energy laser beam on titanium powder to incorporate porosity and surface roughness associated with bone growth activity. K2M received FDA clearance in June for the Mojave PL 3D Expandable Interbody System featuring the Lamellar 3D Titanium Technology, and became one of the first companies to market 3D-printed titanium interbody devices. LessRay (NuVasive). NuVasive commercially launched the LessRay in September 2017. e system uses a proprietary soware algorithm and hardware components to reduce radiation exposure in hospital operat- ing rooms, focused on minimally invasive spine procedures. e image enhancement platform takes low-quality, low-dose images and enhances them to look like full-dose images, which can preserve surgeon and staff longevity without compromising on quality. e platform can also lead to reduced radiation exposure for patients. MANTIS Percutaneous Screw System (Stryker). e MANTIS — minimal access non-traumatic insertion system — Percutaneous Pedicle Screw System is designed for up to three-level procedures in both de- generative and deformity patients. e system's cannulated screw design is based on Stryker's Xia Pedicle Screw system. Surgeons take a true percutaneous approach to the procedure, and precise rod contouring allows for a more anatomic fit. Mazor X (Mazor, Medtronic). Mazor X allows surgeons to develop a plan preoperatively using 3D images of the patient's anatomy. e surgical plan includes implant and trajectory placement that surgeons follow during the procedure; however, they have the ability to change course intraoperatively if necessary. Mazor X is Mazor's next-generation robotic spine system, launched last year. Medtronic made a $72 million investment in Mazor X, purchasing several Mazor X systems and as- suming exclusive global spine market commercial responsibility for the system. Mazor reported 22 system orders in the third quarter of 2017, 11 by Medtronic. Mobi-C (Zimmer Biomet). First approved for use in the U.S. in 2004, Mobi-C has become one of the most popular cervical discs on the mar- ket. e artificial disc has since achieved FDA clearance for two-level procedures and appeared in peer-reviewed literature examining long- term outcomes. Mobi-C demonstrated a 62.8 percent success rate at 60 months aer surgery, compared to 34.1 percent among fusion patients. Mobi-C patients also reported fewer subsequent surgeries, adverse events and lower adjacent level degeneration rates. Return to work was also 21 days quicker for Mobi-C patients than fusion patients. MySpine (Medacta). MySpine is a patient-matched, 3D-printed tech- nology that tailors minimally invasive spine surgeries to the patient's anatomy for more accurate pedicle screw placement. e technology also allows for customization and reduced radiation requirements as well as shorter hospital stays. Surgeons first take a CT of the patient's spine with specific low-dose CT protocol, and Medacta creates a plastic 3D model based on the images to select the best implant position and size. e company then works with surgeons to create personalized instruments and a surgical plan for patients. PathFinder NXT Minimally Invasive Pedicle Screw System (Zim- mer Biomet). e PathFinder NXT Minimally Invasive Pedicle Screw System is Zimmer Biomet's next-generation minimally invasive spinal fusion system, offering enhanced procedural freedom and streamlined workflow. e system includes proprietary decortication and aspira- tion instruments to facilitate solid fusions and the PedicleAccess Tool to streamline the pedicle targeting process and workflow. Originally launched in 2011, the PathFinder NXT System addresses multiple pathologies with a less invasive approach. PediGuard (SpineGuard). e PediGuard probe, a handheld device that detects possible vertebral cortex perforation during pedicle prepa- ration for screw placement, incorporates SpineGuard's DSG Technology. e probe alerts surgeons to breaches by analyzing the electrical con- ductivity of surrounding tissue in real time. PediGuard probes come in a variety of shapes and sizes to address multiple anatomies and approach- es. In June, the company signed an exclusive distribution agreement with XinRong Medical Group to distribute PediGuard in China. Prolix SI Joint Fusion System (Camber Spine). Camber Spine launched the Prolix SI Fusion System in April 2016 as a minimally invasive approach to treat sacroiliac joint pain. e system's approach is between the posterior superior iliac spine and posterior inferior iliac spine. e surgeon first implants a machined cortical bone spacer between the sacrum and ilium through a cannula. en, the surgeon treats the space like a discectomy to promote fusion, as opposed to only limiting joint motion, as occurs when only lateral screws are used. e percutaneous procedure consists of implanting a custom machined allogra through direct visualization and a supplemental lateral fixation of the sacroiliac joint. S4 Element MIS System (Aesculap). e S4 Element MIS system is designed to increase direct surgical site visibility during minimal- ly invasive procedures. e posterior lumbar pedicle screw fixation system uses endoscopic technology to give surgeons a direct view of the surgical site, a comparable view to open procedures. Surgeons can confirm rod delivery, position and length with the system and trouble- shoot issues in real time before they develop into complications. S4 also offers a rescue technique and instrumentation to reduce the risk of open conversion. SiCure Sacroiliac Joint Fusion System (Alevio). e 500th case using Alevio's SiCure Sacroiliac Joint Fusion System was performed in June 2017. is second-generation comprehensive sacroiliac joint fusion sys- tem with titanium screws can be implanted with the lateral or posterior approach. SiCure features a patented dual-lead helical thread design for harvesting and repacking the patient's own bone into the screw as it advances, saving time and reducing biologic material costs. Founded in 2015, the company has grown rapidly over the past two years without reporting significant complications with the technology. SImmetry Sacroiliac Joint Fusion System (Zyga Technology). In April 2017, Zyga enrolled its 100th patient in the EVoluSIon Clinical Study to examine the long-term fusion rate and pain reduction for the SImmetry Sacroiliac Joint Fusion System. Two years aer surgery, 83 percent of the

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