Capitan Orthopedics said it has been granted Breakthrough Device Designation from the FDA for its SupraSpacer implant.
Traditional soft tissue procedures are not possible when the tendon is too damaged or retracted, and for most patients under age 60, a reverse shoulder replacement is not the best option. The SupraSpacer implant is a long-term option designed to restore joint alignment and enable pain-free range of motion, all while preserving future surgical options.
"Addressing irreparable rotator cuff tears with a biomechanical solution that significantly reduces or eliminates pain altogether and increases patient function is paramount. The SupraSpacer is a novel implant technology which provides surgeons with a simple, repeatable, and effective procedure that will have a positive impact on patient outcomes and surgical workflow. It is specifically designed to help maintain the humeral head centered in the joint, reduce the risk and advancement of shoulder arthritis, remove the painful abutment of the humeral head on the undersurface of the acromion, and allow for full impingement-free range of motion," said R. Sean Churchill, MD, MBA, lead surgeon designer.
