Implanet’s Jazz Lock is now cleared in the US and EU
IMPLANET: GREEN LIGHT(S) TO MARKET JAZZ LOCK (Orthopedics This Week)
IMPLANET has announced that it has the green light from the FDA—a 510k clearance—as well as the European CE mark for its new Jazz Lock implant. Let the marketing begin.
According to the April 5 2016 news release, “Jazz Lock is the first of an innovative range of band products designed for degenerative spine disorder surgery. This new implant expands the JAZZ technological platform and allows Implanet to broaden its activity to the cervical spine, estimated at over $200 million worldwide. Based on the polyester sublaminar braid platform, Jazz Lock eliminates the mechanism’s locking screw and connecting rod, thanks to a proprietary fastening locking system. Implanet thus offers surgeons a new implant with an optimized and reproducible surgical technique.”
Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, stated, “Constant innovation is the essential component in maintaining our technological advantage. Over the last two years, we have focused our efforts on finalizing our range of Jazz Band implants, notably with the market’s most extensive range of connectors, to ensure compatibility with all existing posterior fixation systems. A result of collaboration with leading surgeons, Jazz Lock represents a major breakthrough: an innovative, IP protected design offering surgeons a fusion device that no other company currently can.”
Implanet CEO Ludovic Lastennet added, “Obtaining regulatory clearances to market this new major component of our Jazz Band platform is a significant milestone in terms of product range expansion. Already established in the major spinal deformity segment, we are now accelerating our presence in the degenerative bone disorder segment, which is three times larger. Jazz Lock is the first component of an innovative range of band products for degenerative spine disorder surgery targeted for launch in the near future, in line with our execution plan. Jazz Lock’s commercial launch is underway and further expands the breadth of our product offering.”
Lastennet told OTW, “We have developed a polyester braid platform that allows for cerclage around bony structures such as lamina or transverse process. The same braid can be used for different spinal indications: deformations such as AIS [adolescent idiopathic scoliosis], trauma and degenerative surgeries. For each of these indications the surgeon can choose to use the braid with different types of connectors: JAZZ that connects to a rod and exists in 5 different diameters from 3.5 mm to 6.0 mm; JAZZ Lock that allows for wiring techniques without the use of a rod.”
“Over the next quarters, we will continue to launch new connectors to be integrated in this braid technology platform to address the deformity, degenerative and trauma vertebral fusion market.”