In 2015, it was interbody cages, sacroiliac joints, artificial discs and robotics. This year, enabling technologies of all kinds generated the most pre- and post-event buzz. Implants made with 3D printing technologies were highlighted, too, as were companies’ responses to changes in healthcare delivery.
Below, we share extended detail on these three topics and follow with a summary of other news captured during NASS week.
These span systems that support pre-surgical planning, surgical navigation, alignment, etc.
DePuy Synthes Spine launched the KICK portable 2D spine imaging system with FluoroExpress Software Module, created through a partnership with Brainlab. Working with a hospital’s existing X-ray equipment, KICK is designed to provide access to affordable advanced imaging technology with real-time navigation for pedicle screw placement. (KICK was one of seven spine products noted in JNJ’s pipeline out through 2018, shared during the company’s 2016 Business Review Day.)
KB Medical announced a raise of CHF 2.5MM (~US $2.51MM) in Series B Financing. Funds will support FDA clearance for the AQrate Robotic Assistance System V 1.2 for spinal surgery. The product presently has CE Mark approval, and limited launch will begin in 2017.
AQrate comprises hardware and software to support intra-op haptic steering. While its first iteration is focused on the spine, the company has noted potential application in orthopaedics from head to toe.
Mazor Robotics commenced commercial launch of the Mazor X surgical assistance platform, which hit the market with 6 pre-orders and a purchase order from Medtronic for 15 systems, four of which were delivered in 3Q16.
Mazor X differs from the company’s Renaissance product in a number of ways, not the least of which is intra-op guidance via a robotic arm that is bed-attached and bone-mounted to guide surgical tools and implants per pre-op analytic information. Real-time 3D verification confirms execution and reconciliation of the surgical plan.
The promotion and development of Mazor X is supported by a partnership with Medtronic, including an equity investment from the leader in spine.
Medacta completed initial U.S. surgeries using its proprietary MySpine patient-matched, low profile, 3D-printed surgical planning guide, following FDA clearance at the end of 2Q16. The guide is intended to help identify pedicle entry points, screw trajectories and implant specifications to potentially increase accuracy and outcomes.
NuVasive introduced an Integrated Global Alignment (iGA) platform that is expanded to support cervical alignment. The new launch also includes Bendini OCT, a computer-assisted rod bending system with new application in occipito-cervico-thoracic cases, for use with NuvaPlanning software and NuvaMap O.R. real-time intra-op assessment of correction.
Spinal Elements and Mighty Oak Medical partnered to co-market the FIREFLY surgical guidance system, comprising patient-matched bone models and intra-op pedicle screw guides created via 3D printing. FIREFLY Pedicle Screw Navigation received FDA clearance in late 2015, requires no capital equipment and may reduce intra-op imaging and radiation exposure. (A second FDA clearance came through right at press time, extending compatibility to essentially all currently cleared pedicle screw systems and extending indications to include the T1-S2/ilium region.)
Synaptive Medical attended NASS for the first time and showcased BrightMatter robotic arm/visualization technology. A camera, mounted on the arm, automatically follows the instruments in a surgeon’s hands and projects the field of view onto a monitor viewable in the O.R.
3D Printing Technology
K2M showcased its complete portfolio of CASCADIA devices, and commenced U.S. launch of these interbody systems that feature Lamellar 3D Titanium technology. Lamellar technology uses 3D printing to create porous structures that support bony integration throughout an implant, with similar stiffness to PEEK.
Products available in the line include CASCADIA TL, AN, Lateral, AN Lordotic Oblique and Cervical interbody systems. The company announced FDA clearance for additional sizes of the lateral system shortly prior to NASS. Further, leadership noted that CASCADIA products buoyed the 21% growth in K2M’s degenerative product sales for 3Q16.
Stryker demonstrated its 3D-printed Tritanium Posterior Lumbar cage, accompanied by results from a pre-clinical ovine interbody fusion study that compared the device to PEEK and titanium plasma-sprayed PEEK cages. The results demonstrated statistically superior range of motion, bone in-growth and greater average construct stiffness with the Tritanium cage vs. PEEK and titanium plasma-sprayed PEEK cages.
Stryker received FDA 510(k) clearance for the 3D-printed Tritanium PL cage at the end of 2015 and debuted the device in 2Q16.
Value-based Healthcare Solutions
Ascential has launched to offer an implant and delivery solution for lower-acuity spinal procedures in ambulatory surgery center and hospital settings. Implants are manufactured by Stryker and include synthetic bone graft and a cervical plate and cervical spacer in sterile double blister packs with touch-free bone screw loading. All implant packaging is Unique Device Identification compliant.
Ascential also offers a streamlined distribution model, and its inventory management program can be customized based on variables such as a facility’s number of spine cases, surgical days, number of surgeons, etc.
As promised, here's everything else announced during the week of NASS 2016.
|4WEB Medical||Completed first surgeries using the Curved Posterior Spine Truss system for TLIF procedures|
|Alphatec Spine||Received FDA 510(k) for Battalion Lateral Spacer, with Squadron Retractor|
|AMNIOX Medical||Study results from proprietary cryopreserved Amniotic Membrane as an adjunct to lumbar discectomy indicated improved outcomes in disability scores at 6 weeks and 2 years|
|AxioMed Spine||Announced introduction of the Freedom cervical and lumbar discs in Australia|
|DeGen Medical||Introduced the Latitude-C Porous Ti Cervical Interbody Spacer|
|DePuy Synthes||Launched the ZERO-P NATURAL Plate, designed for use with the CC Natural allograftspacer; launched SYNFIX Evolution for standalone Anterior Lumbar Interbody Fusion|
|Genesys Spine||Launched the TiLock Cortical Spinal System to provide an anatomy-conserving alternative to traditional pedicular fixation|
|Globus Medical||Launched the QUARTEX OCT Stabilization System and the INDEPENDENCE MIS integrated ALIF plate/spacer|
|Life Spine||Launched e-LIF Expandable Lateral Interbody Fusion|
|Medicrea||Announced a lifetime warranty on its patient-specific UNiD technology implanted in the U.S.|
|NuVasive||Acquired LessRay software technology from SafeRay Spine; intended to manage radiation exposure, and integrates into an O.R.’s existing C-arm workflow|
|NuVasive Specialized Orthopedics||Received FDA clearance for magnetic resonance imaging under certain conditions on patients treated with the MAGEC growth modulation system|
|Orthofix||Announced NASS’ first of its kind coverage recommendations for electrical bone growth stimulators as an adjunct to spinal fusion, supporting use of pulsed electromagnetic field stim devices, such as CervicalStim and SpinalStim|
|Pinnacle Spine||Launched the InFill V2 Lateral Interbody Device, featuring a large, single graft chamber and a large load-bearing surface area|
|Precision Spine||Officially debuted the MD-Vue lateral access system|
|RTI Surgical||Received an expanded FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System, including an indication for polyaxial screw placement in the cervical spine, and also clearance for a dual diameter transition rod|
|SeaSpine||Received FDA 510(k) clearance to market the Shoreline ACS Anterior Cervical Standalone system (full commercial launch slated for 1H17)|
|Signus||Announced FDA 510(k) clearance to market the DIPLOMAT pedicle screw|
|Spinal Elements||Announced initial procedures using the Katana minimally invasive lateral system|
|Spine Wave||Announced November full launch of the Velocity P Expandable Interbody Device system|
|SpineGuard||Officially launched next-gen PediGuard Threaded instrument, enabled by Dynamic Surgical Guidance|
|Spineology||Announced completion of 100 cases using the Palisade Pedicular Fixation System. Received FDA 510(k) clearance to market the Rampart Duo Interbody Fusion System, reportedly the first device to combine PEEK, titanium and graft containment mesh elements|
|Theracell and AlloSource||Announced pending issuance of a U.S. patent for DBF demineralized bone fiber, part of AlloSource’s AlloFuse Cortical Fibers and AlloFuse Fiber Boats|
|Tyber Medical||Fully launched lateral access, next-gen lateral PEEK/titanium composite interbody and lateral plating systems|
|Vertera Spine||Announced initial successful outcomes using the COHERE Cervical Interbody Fusion device|
|Zimmer Biomet||Announced that the Vitality fixation system has been used in 1,500 surgeries following 2Q16 launch. Shared 2-year results from trial indicating that the Aspen MIS Fusion system is a clinically effective alternative to pedicle screw fixation. Announced that Mobi-C is now the most widely-covered device by U.S. commercial health insurers for 1- and 2-level cervical disc replacement. Shared 7-year outcomes study data demonstrating statistical superiority of Mobi-C vs. 2-level ACDF in overall success|