Therapy Areas: Devices
CoNextions awarded FDA clearance for TR Tendon Repair System
26 April 2022 -

Medical device company CoNextions Inc reported on Monday the receipt of US FDA 510(k) clearance for CoNextions TR Tendon Repair System for soft-tissue repair leading to improved patient outcomes.

With expected availability in May 2022, the novel CoNextions TR Tendon Repair system addresses traumatic tendon lacerations in the hand, wrist and forearm, the company added.

The company is encouraged with the outcome of the US FDA review of its 510(k) submission supported by 90% patient clinical trial and are excited about the upcoming introduction and commercial launch of the product, its president and CEO Jeffrey Barnes stated.

CoNextions TR enables a stronger, faster and smoother repair of tendon lacerations. A prospective randomized clinical trial also showed a lower rate of treatment failure and rupture compared to conventional suture repairs. The CoNextions TR device is another example of CoNextions' commitment to providing innovative and advanced solutions, added EVP of Sales and Marketing, Dan Gruppo.