FDA clears use of InSpace balloon implant to treat massive irreparable rotator cuff tears
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Stryker received FDA clearance of its biodegradable InSpace balloon implant which replaces the need for complicated rotator cuff surgeries by restoring subacromial space in the shoulder, according to a company press release.
“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 a clinical study on the implant, said. “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.”
The system provides arthroscopic treatment of massive irreparable rotator cuff tears and shows improvements in shoulder motion and function, the company said in the release.
The implant has been clinically successful for more than 10 years and Stryker acquired it from OrthoSpace Ltd in 2019. The device is “the first of its kind in the U.S. market,” according to the release, and 29,000 have been implanted in procedures in other countries.
According to Stryker, the treatment is ideal for patients 65 years or older who have damage to the rotator cuff tendons and have mild to moderate glenohumeral osteoarthritis.
“We are committed to the advancement of shoulder arthroscopy, and InSpace offers a unique opportunity for us to better partner with our customers on their clinical objectives to improve patient outcomes around a challenging pathology in the shoulder,” Matt Moreau, sports medicine vice president and general manager at Styker, said.
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