Anika Therapeutics, a devicemaker focused on joint preservation, received FDA 510(k) clearance for its Integrity Implant System, which is planned to launch in the first quarter of 2024.
The system is intended to enhance the healing process following rotator cuff procedures by strengthening the injured tendon, and the hyaluronic acid-based patch was the final component to receive clearance, according to an Aug. 17 press release from Anika Therapeutics.
The implant is an HA-based scaffold with a knitted structure meant to increase flexibility, strength and regenerative capacity in comparison to first-generation collagen patches. The HA technology allows the patches to reabsorb as the tissue remodels over time and be manipulated arthroscopically.
The patches combined with fixation implants and single-use arthroscopic delivery instruments are meant to enhance cell infiltration, tissue remodeling and tendon thickening within the healing process, according to the release.