The U.S. Food and Drug Administration (FDA) has cleared the first ever biodegradable subacromial balloon spacer developed by OrthoSpace Inc. and acquired by Stryker. The balloon, called InSpace, is the first implant for arthroscopic treatment of MIRCTs (massive irreplaceable rotator cuff tears) through restoring the subacromial space without fixation devices or sutures to improve shoulder functionality and is a first for the US market. “We are extremely excited about the clearance of InSpace because it provides a new surgical option for surgeons to address their unmet MIRCT needs in the shoulder continuum of care. 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 very challenging pathology in the shoulder,” stated Matt Moreau, Stryker’s Sports Medicine VP and GM.
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