The FDA cleared Stryker's InSpace balloon implant for arthroscopic treatment of rotator cuff tears, the company said July 13.
InSpace is used for irreparable rotator cuff tears and is designed to restore the subacromial space without needing sutures. The technology was acquired from OrthoSpace, and it has been implanted in 29,000 cases internationally.
"Current strategies treating massive irreparable rotator cuff tears often present a challenge to surgeons and may require long and frustrating rehabilitation processes for patients," Nikhil Verma, MD, lead investigator of InSpaces clinical study. "The results of the study demonstrate the InSpace balloon is a 'game-changer' and presents a shorter, less invasive option that may enable sustained, clinically meaningful improvements in shoulder function and symptoms."