ZuriMED Secures FDA Clearance for its FiberLocker System

Rotator cuff tears are among the most prevalent shoulder-related ailments, affecting a vast segment of the population. Traditional repair techniques often fail at the suture-tendon interface, leading to retears that necessitate further surgeries and extend recovery times. Committed to resolving this critical issue, ZuriMED has introduced the FiberLocker System. This novel technology reinforces soft tissue repairs at the time of surgery in an effort to improve traditional repair techniques.

ZuriMED’s FDA-cleared medical device comprises two components: A patch (SpeedPatch PET), which is implanted onto the repaired tendon, and a single-use instrument (FiberLocker Instrument SN), designed to facilitate its fixation. Hereby, the startup has been translating an established technology from the textile industry into medicine - felting. 

Made of non-woven polyethylene terephthalate (PET) fibers, the patch acts as medical felt. During surgery, the FiberLocker Instrument SN employs a reciprocating needle that pushes the fibers into the underlying tendon tissue, creating an interwoven construct that securely integrates the implant to the tendon. 

Unlike other augmentation methods, the FiberLocker System simplifies the fixation process and establishes a new method for soft tissue repair by offering immediate, enhanced biomechanical support. “I truly believe that ZuriMED’s unique technology has the potential to become a game changer in shoulder surgery by helping us to improve patient’s outcomes. The application of the device is simple and fast and has shown to reinforce traditional repair techniques,” said Prof. Dr. Karl Wieser, Head of Shoulder and Elbow Surgery at Balgrist University Hospital.

Pre-Clinical Data: A Robust Foundation for FDA Clearance

Comprehensive ex vivo biomechanical testing has supported the enhanced suture retention and even load distribution across the implant achieved with the FiberLocker System. The technology facilitates an arthroscopic procedure, streamlining the surgical process with a rapid, 90-second patch-to-tendon fixation.

Further supporting its clinical utility, in vivo animal studies have confirmed the excellent biocompatibility of the SpeedPatch PET, with no adverse effects noted up to 13 weeks post-implantation. The implant was well-tolerated and integrated with the tendon, evidenced by a smooth transition between the patch and tendon tissues and cellular ingrowth into the porous scaffold.

With the recent clearance of the FiberLocker System, ZuriMED is driven by the ambition to leave a long-lasting impact on the medical technology landscape. The company anticipates a limited U.S. market release of the SpeedPatch PET and FiberLocker Instrument SN in early 2025. 

(Press release / SK)