French spinal device company Implanet says its JAZZ Band™ posterior fixation anchor can now be used with other posterior thoraco-lumbar fixation systems (screws, rods, hooks) available on the market. A new U.S. FDA 510(k) clearance removes the limited intended the use of the JAZZ Band platform with the Implanet Spine System.
Headquartered in Bordeaux, France, Implanet is a medical technology company specializing in vertebral and knee-surgery implants. Founded in 2007, the company’s flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained U.S. FDA 510(k) regulatory clearance and is CE marked.
Until now its FDA clearance limited the JAZZ Band system to use in conjunction with Implanet’s own spine system. With the removal of this restriction surgeons can now elect to use the bony anchor, designed to guarantee temporary stabilization for bony fusion or for consolidation of a fracture, with thoraco-lumbar fixation systems from other manufacturers.
This latest FDA clearance follows that obtained in June for the expanded JAZZ Band range, allowing the Company to respond to all surgeon requests through the offer of a comprehensive range covering various diameters.
Ludovic Lastennet, CEO of Implanet, says: “We had been eagerly awaiting this latest clearance, which represents a major milestone in our development. Surgeons may now utilize their posterior fixation system of choice when incorporating JAZZ into their hybrid constructs. On a clinical level, this clearance will also allow us to initiate extensive multicenter prospective studies in the United States. It sends a strong signal less than a month from the start of major spine surgery conferences, the SRS and NASS annual meetings, and we are confident that this latest clearance will enable us to accelerate our technology’s regulatory process in other countries with substantial market potential.”
Source: Business Wire