Anika Therapeutics received FDA 510(k) clearance to market the Integrity Implant, a system designed to augment an injured tendon to promote healing in rotator cuff repair.
Limited U.S. launch is slated for 1Q24, with a full U.S. market release and expansion into international markets to follow.
Clearance of the hyaluronic acid (HA)-based patch component joins prior 510(k)s received for the associated fixation devices and instrumentation. The Integrity implant is a flexible knitted HA-based scaffold that provides improved strength and regenerative capacity over first-generation collagen patches, and supports regenerative healing through improved cell infiltration, tissue remodeling and tendon thickening.
The system comprises the HA-based patch implant, fixation implants and single use arthroscopic delivery instruments. The patch component is a porous, flexible construct knitted using HYAFF fibers, and is designed to support cell infiltration and regenerative healing. HYAFF is Anika’s proprietary esterified HA technology that resorbs over time as tissue remodels.
Integrity is inherently strong and can be confidently manipulated arthroscopically. The Integrity patch implant is fixed using PEEK bone staples, resorbable PLGA soft tissue tendon tacks or suture fixation as desired, at the site of the rotator cuff augmentation. The fixation components and instrumentation are delivered single use and sterile for added efficiency.
Anika Therapeutics received FDA 510(k) clearance to market the Integrity Implant, a system designed to augment an injured tendon to promote healing in rotator cuff repair.
Limited U.S. launch is slated for 1Q24, with a full U.S. market release and expansion into international markets to follow.
Clearance of the hyaluronic acid (HA)-based...
Anika Therapeutics received FDA 510(k) clearance to market the Integrity Implant, a system designed to augment an injured tendon to promote healing in rotator cuff repair.
Limited U.S. launch is slated for 1Q24, with a full U.S. market release and expansion into international markets to follow.
Clearance of the hyaluronic acid (HA)-based patch component joins prior 510(k)s received for the associated fixation devices and instrumentation. The Integrity implant is a flexible knitted HA-based scaffold that provides improved strength and regenerative capacity over first-generation collagen patches, and supports regenerative healing through improved cell infiltration, tissue remodeling and tendon thickening.
The system comprises the HA-based patch implant, fixation implants and single use arthroscopic delivery instruments. The patch component is a porous, flexible construct knitted using HYAFF fibers, and is designed to support cell infiltration and regenerative healing. HYAFF is Anika’s proprietary esterified HA technology that resorbs over time as tissue remodels.
Integrity is inherently strong and can be confidently manipulated arthroscopically. The Integrity patch implant is fixed using PEEK bone staples, resorbable PLGA soft tissue tendon tacks or suture fixation as desired, at the site of the rotator cuff augmentation. The fixation components and instrumentation are delivered single use and sterile for added efficiency.
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