CoNextions was granted FDA 510(k) clearance to market the CoNextions TR® Tendon Repair System. Expected to launch in May 2022, the novel system addresses traumatic tendon lacerations in the hand, wrist and forearm.
Studies have demonstrated that CoNextions TR supports a strong, fast and smooth repair of tendon lacerations. A prospective randomized clinical trial also showed a lower rate of treatment failure and rupture compared to conventional suture repairs.
"We are pleased with the outcome of FDA's review of our 510(k) submission supported by a ninety-patient clinical trial, and are excited about the upcoming introduction and commercial launch of the product," said Jeffrey Barnes, President and CEO of CoNextions.
Source: CoNextions Inc.