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Current & Critical

NASS Recap: Product Updates and Highlights

Despite continual challenges regarding regulatory clearance, reimbursement and market penetration, sentiment from manufacturers at the North American Spine Society (NASS) meeting in San Francisco indicated that the spine market is stabilizing and presenting greater opportunities than in recent years. An advent of more differentiated and more minimally invasive technologies is expected to play a role in driving market growth.

Dozens of companies announced product launches and updates in preparation for NASS. A full list of recent spine announcements can be found by clicking here. We’ve compiled below a list of the more notable technologies and milestones.

4WEB Medical
3D-Printed Truss Implants

  • Announced that surgeons have implanted >3,000 3D-printed orthopaedic truss devices, including cervical and ALIF interbody applications
  • Designed to allow up to 75 percent of implant to be filled with graft material
  • Announced plans to add TLIF, PLIF, OLIF and lateral spine designs in 2Q15


Biomet Spine
Timberline™ Modular Plate Fixation Hyperlordotic Lateral Fusion System

  • Completed first surgery using the lateral fusion system, reportedly first of its kind cleared by FDA for use in the lateral approach
  • Used to facilitate increased sagittal correction in deformity correction and additional complex lumbar pathologies


Centinel Spine
Ti-ACTIVE™ titanium coating

  • Launched Ti-ACTIVE™ titanium coating, featured on the STALIF C-Ti device, reportedly the first titanium-coated, No-Profile® Anterior Cervical Integrated Interbody™ System on the market
  • Coating created to deliver enhanced fixation, increased primary stabilization and bony on-growth


LDR
Mobi-C®

  • Presented study results demonstrating that Mobi-C is a highly cost-effective surgical option vs. anterior cervical disc fusion for 2-level indications
  • Don’t expect two-level competition on the horizon
  • “We have very consistent results going from one-level cervical disc replacement to two-level cervical disc replacement, meaning there’s not a significant falloff in clinical outcomes,” says Joe Ross, Executive Vice President of Global Marketing. “When you go from one-level fusion to two-level fusion, there [is] a significant decrease in overall efficacy. What we feel surgeons are beginning to realize is that two-level fusions don’t do as well as they thought they did.”
  • Continued company focus on a smaller number of differentiated products, not becoming full-line spine company


Medicrea
UNiD™

  • Received FDA 510(k) clearance to market UNiD, reportedly the first patient-specific spinal osteosynthesis rod
  • “We designed an extra plug in application with Surgimap software that allows the surgeon to fully simulate this surgery, fully plan, select his implants and design his rods perfectly for that patient, using all the science that has been shown and published on sagittal alignment,” says David Ryan, Vice President Product Development and Marketing.
  • Delivered within five working days after surgeon validates rod design
  • Reportedly reduces operating time by 15-30 minutes by eliminating the need to manually bend a rod
  • Completed >100 surgeries in Europe
  • Developed team to work with surgeons preoperatively and postoperatively on patient analysis


Precision Spine
MD-Max™ and VAULT®-C

  • Introduced MD-Max™ ULIF (Universal Lumbar Interbody Fusion) Minimally Disruptive, Maximum Access retractor system
    - Designed to support results equal to or better than the classic open approach
    - Employed by the Extended Tab SureLOK™ C Screw System with breakaway tabs at 10mm increments to support improved access, and an open tulip design for facilitating easier rod insertion
    - “It is pedicle-screw based, but it’s not only unilateral, but contralateral,” says Donald Kucharzyk, D.O., lead development surgeon on the device. “You’re placing four pedicle screws and allowing uniform distraction of the disc space, as opposed to some of the unilateral pedicle screw systems that are open-book type of distractions. It prevents you from putting in the interbody graft abnormally and putting it into the endplate [as may sometimes happen].”
  • Received FDA 510(k) clearance and commenced launch of the VAULT-C Anterior Cervical Interbody Fusion Device
    - Integrated plate/cage design supports rigid screw fixation using a zero profile construct, which is intended to limit damage to surrounding vessels and adjacent soft tissue
    - Designed to offer larger graft chamber and separate plate and cage construct assembled on back table, which gives surgeon and patient more variability with sizing


SI-BONE
iFuse Implant System®

  • Presented five-year study for iFuse in minimally invasive sacroiliac joint fusion that showed long-term durability of positive clinical outcomes
  • Announced European expansion through formation of GmbH in Germany


Stryker Spine
Aero™-AL

  • Launched anchor-based technology, reportedly the only in-line ALIF device that compresses across the interbody space to support a less-disruptive approach vs. traditional screw-based technologies


Titan Spine
Endoskeleton®

  • Received FDA 510(k) clearance to market Endoskeleton® interbody fusion implants featuring nanoLOCK™ surface technology
  • Reportedly first clearance of nanotechnology interbody devices by FDA
  • Surface formed by reductive process of the titanium, not by coating application
  • Offering a warranty for Endoskeleton devices, providing a one-time free replacement of any eligible Titan spinal interbody fusion device if revision surgery is required within the five-year warranty period


Zimmer Spine
Optio-C®

  • Received FDA 510(k) clearance to market the anterior cervical plate for use with structural allograft/autograft as a standalone system for fusion procedures
  • System comprises one plate, three bone screws and a PEEK IBFD or structural allograft/autograft, and secured by anti-migration system designed to maintain no profile


Carolyn LaWell is Content Manager at ORTHOWORLD®. She can be reached by email.