FDA clears rotator cuff repair implant from Anika Therapeutics

Anika Therapeutics (Nasdaq:ANIK) announced that it received the final FDA 510(k) clearance for its Integrity implant system.

Bedford, Massachusetts-based Anika designed Integrity to augment an injured tendon, promoting healing in rotator cuff repair procedures. This clearance for the hyaluronic acid (HA)-based patch component joins previous clearances for associated fixation devices and instruments.

The company describes Integrity as a flexible, knitted, HA-based scaffold. It provides improved strength and regenerative capacity compared to first-generation collagen patches. The implant supports regenerative healing through improved cell infiltration, tissue remodeling and tendon thickening.

“The clearance of Integrity is a key milestone in the continued build-out of Anika’s proprietary HA-based regenerative portfolio and underscores our commitment to helping surgeons improve outcomes in rotator cuff repair procedures through biologic healing,” said Chery…

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