NASS Recap 2016

nassIn 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. (All images courtesy of manufacturers.)

 


 


Kick System Camera and Monitor Stands 3

DePuy Synthes Spine's
Kick portable 2D spine
imaging system

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AQrate System full copyright 4

KB Medical's AQrate
Robotic Assistance
System 


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MazorX System 2 resie

Mazor X
surgical assistance
platform
  

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Surgical Assistance
These span systems that support pre-surgical planning, 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.

 

Next: 3D Printed Devices and Value-Based Healthcare Tools



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stryker
Stryker's 3D-printed
Tritanium Posterior
Lumbar cage

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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. 


 

DeGen Medical forweb  Genesys forweb  Medicrea forweb
DeGen Medical's
Cervical Interbody Spacer
Genesys Spine's TiLock
Cortical Spinal System
 
 Medicrea's
UNiD Cervical Rods

Pinnacle forweb

Spineology forweb zimmer forweb 
Pinnacle Spine's InFill V2
Lateral Interbody Device
Spineology's Palisade
Pedicular Fixation System
Zimmer Biomet's Vitality
fixation system

 



Other announcements from NASS week 2016 include:

   Company   Details
  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 allograft spacer;
  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


  Sources: Company press releases, web sites, articles in the public domain