CoNextions Medical completed enrollment in the clinical trial for the CoNextions TR tendon-to-tendon repair device. The company plans to submit a 510(k) application to FDA in 1Q20.
CoNextions TR is based on a coupler system that offers an alternative to sutures for surgical repair of digital flexor and extensor tendons. The system enables rapid, strong, low profile and reproducible repair in any lacerated or ruptured tendon appropriately sized for the device in the hand, wrist, forearm, foot and ankle.
The 80-patient multi-center, blinded randomized clinical trial compared CoNextions TR to the standard of care suture repair of Zone 2 flexor tendon lacerations, with a primary goal to demonstrate safety and efficacy. CoNextions Medical will release trial data following completion of 12-week follow-up.
Source: CoNextions Inc.