“Strapping” fixation without screws is cleared in Europe
IMPLANET’S “STRAPPING” STABILIZATION SYSTEM CLEARED IN EUROPE (Orthopedics This Week)
Implanet’s newest addition to its spinal stabilization system using a strapping or banding method instead of inserting pedicle screws and rods has received European marketing clearance (CE).
A May 3, 2017 clearance announcement of the JAZZ Standalone implant states the implant is part of the company’s freestanding, rodless fixation line launched in 2016 with the JAZZ Lock implant. According to the company, the implant offers “fast and simple” freestanding posterior fixation to replace traditional fixation systems.
No Screws or Rods
Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, stated, “The result of our work with thought leading surgeons, the JAZZ Standalone is a new variant of our JAZZ technology devoted to treating degenerative pathologies. This implant utilizes the JAZZ Band platform and enables vertebral segments to be stabilized without the need for pedicle screws and rods. This is a fast, simple and safe surgical procedure that only requires limited surgical accessibility.”
Ludovic Lastennet, Implanet CEO, added, “We are continuing to rigorously pursue our execution plan by regularly marketing new products and line extensions. The marketing approval of a major new component of the JAZZ Band platform in Europe is another key breakthrough in terms of expanding the range. Indeed, the JAZZ Standalone meets a major and persistent demand from surgeons regarding their need to continually simplify surgical procedures. It should rapidly be adopted by our partners, whether they be pediatric surgeons or surgeons specializing in adult degenerative disorders.”
The company says the unique banding, or strapping system, offers a “credible and efficient” alternative, addressing the problems encountered with the metal cable systems. The stated benefits of the JAZZ lock system include:
- Connector for independent locking band for later treatment of cervical levels
- Bone/implant interface: braided belt fits the anatomical structures
- Simple and rapid implementation
- Open and flat polyester Band coming from the JAZZ Platform: Proven concept
- No metal in the canal = no artifact
- Single tensioning instrument for reduction and correction of the spine based on JAZZ Platform
- Optimal instrumentation only made of 4 instruments, with 3 common to the Jazz platform
- Limited learning curve due to the simplicity of the implant and instrumentation solution
The company was founded in Bordeaux, France, in 2007 and established a U.S. subsidiary in Boston in 2013. Sales in 2016 were €7.8 million ($8.4 million). In 2016, the company also reported a 46% growth in JAZZ implant system sales.