SALT LAKE CITY, Sept. 5, 2019 /PRNewswire/ — CoNextions Medical, a developer of novel soft tissue repair devices, announced today that it has completed enrollment in a key clinical trial for its pioneering tendon-to-tendon repair device, CoNextions TR. Pending successful results of the trial, the company plans to submit a 510(k) application to the FDA for US marketing approval in the first quarter of 2020.
The CoNextions TR device is based on a pioneering technology coupler system that provides a revolutionary alternative to sutures in tendon-to-tendon approximation and repair. CoNextions TR allows surgeons to produce a 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 trial is a multi-center, blinded, randomized clinical trial comparing the CoNextions TR device to the standard of care suture repair of Zone 2 flexor tendon lacerations. Zone 2, often referred to as ‘no man’s land,’ is widely recognized as the most challenging area for tendon repair. The study’s primary goal is to demonstrate safety and effectiveness of the CoNextions TR device. CoNextions Medical plans to release trial data from the trial following completion of a 12-week follow up period and analysis of the results.
“The interest and enthusiasm of the study investigators in this revolutionary device underscore the interest among surgeons for a better means to address this most difficult tendon repair scenario,” said Jeff Barnes, the CEO of CoNextions Medical. “We appreciate the collaboration with the patients, surgeons, physical therapists, and study personnel as they all have been committed to advance the quality of care and improve outcomes of tendon repair.”
About CoNextions Inc.
Founded in 2011, CoNextions Inc. is a privately-held company located in Salt Lake City, Utah. They are an innovation-based medical device company whose mission is while putting quality first, improve the lives of patients by revolutionizing soft tissue repair with safe, innovative, and easy to use medical devices. Learn more at www.conextionsmed.com