Medical device firm Capitan Orthopedics received breakthrough device designation from the FDA for its SupraSpacer implant.
The designation applies to the company’s implant designed to treat irreparable rotator cuff tears, according to an April 30 company news release.
Rotator cuff injuries affect more than 2 million people each year, with more than 700,000 undergoing surgery. Patients with severe tears often have limited treatment options when standard repair procedures are not viable.
The SupraSpacer implant is intended to restore joint alignment and improve range of motion while preserving future surgical options.
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