The clinical trial will compare the CoNextions TR device to the standard of care suture repair of Zone 2 flexor tendon lacerations
Image: The clinical trial evaluates CoNextions TR device. Photo: Courtesy of mrdjrlawrence from Pixabay.
CoNextions Medical, a US-based tendon repair surgical equipment manufacturer, has completed enrolment for a clinical trial of its tendon-to-tendon repair device, CoNextions TR.
The company is planning to submit a 510(k) application to the FDA for US marketing approval, following the completion of the trial, in the first quarter of 2020.
CoNextions Medical CEO Jeff Barnes said: “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.
“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.”
The clinical trial compares CoNextions TR device to the standard of care suture repair of Zone 2
The CoNextions TR device is designed based on an advanced technology coupler system that offers an alternative to sutures in tendon-to-tendon approximation and repair.
In addition, the device allows surgeons to produce a rapid, strong, low profile, and reproducible repair in any lacerated or ruptured tendon, and is appropriately sized for the hand, wrist, forearm, foot, and ankle.
The clinical trial designed to enrol 80 patients is a multi-centre, blinded, randomised study that compares the CoNextions TR device to the standard of care suture repair of Zone 2 flexor tendon lacerations.
CoNextions said that the study is primarily aimed at demonstrating safety and effectiveness of the CoNextions TR device and it is expected to release the data from the trial after completion of a 12-week follow up period and analysis of the results.
CoNextions Medical was founded in 2011 in Sandy, Utah, US, and is a medical device company engaged in developing safe, strong, and more durable tendon repairs, for faster rehabilitation, fewer complications and lower long-term costs.