Implanet granted regulatory clearance in the USA (510k) and Europe (CE) for the Jazz Claw
Bordeaux, Boston, May 23, 2016 – IMPLANET (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has been granted 510(k) clearance in the United States and the CE Mark in Europe to market the new Jazz Claw®.
Jazz Claw is an unmatched hybrid implant providing autostable posterior fixation, replacing traditional hook-and-screw fixation systems. Jazz Claw is designed to treat complex degenerative pathologies in adults (kyphosis), a growing indication driven by the aging population. Jazz Claw compliments Implanet’s growing product portfolio devoted to degenerative pathologies, which represent the largest spine surgery market segment. In addition, its autostable characteristics aid in the treatment of adolescent scoliosis with hybrid fixation.
Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “Jazz Claw is Implanet’s response to the complex issue of securing the top of constructs in adolescent scoliosis and adult degenerative deformities. This biomechanically challenging area was traditionally treated with pedicle screws or hooks, with inherent drawbacks that the Jazz Claw eliminates. The result of a collaboration with prominent surgical teams, Jazz Claw is a new hybrid solution that provides ease of use, versatility and the power of sublaminar band reduction in a high demand location.”
Ludovic Lastennet, CEO of Implanet, adds: “We continue to execute our business plan and product-launch schedule in a timely fashion. Jazz Claw is a major new component of our Jazz Band® platform, an implant that supplements our product offering for major deformities and meets a major market demand. In this respect, it should rapidly be adopted by our partners, whether specializing in pediatric or adult degenerative indications.”.
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