Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

By Julie A. Vetalice

Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

Via Surgical, a leading developer of novel surgical fixation solutions, announced today it has received 510(k) clearance by the U.S. Food and Drug Administration for the TissueTak™ tendon anchor. It is the first suture-based fixation system to be used for arthroscopic rotator cuff repair and augmentation.

TissueTak™ is a trademark owned by Arthrex, Inc.

The TissueTak system utilizes a suture-based anchor to attach the patch directly to the patient’s tendon, providing a high-strength alternative to traditional surgical staples or suture techniques which are inefficient and difficult to place. Multiple fasteners are deployed using an ergonomically-shaped device that inserts each faster to affix a biological patch to the patient’s own tissue without reloading or removing the device from the joint.

Via Surgical’s fasteners are more secure than traditional staples due to a proprietary closed lock-loop suture concept, as evidenced in usability tests in cadaver tissue. The suture-like implants can be quickly and easily deployed through laparoscopic incisions. This helps make the procedure more efficient and less complex for both the doctor and operating room staff. For patients, the new system can result in a reduced amount of time in the OR, less pain, and provides a reproducible procedure to reduce retear rates following rotator cuff repair.

Source: Via Surgical

Product Labels: Arthroscopy Equipment

Tags: 510(k) Clearance, Regulatory