Anika Therapeutics, Inc. announced that it has received the final 510(k) clearance from the FDA for the Integrity? Implant System. The system is designed to augment an injured tendon to promote healing in rotator cuff repair procedures.

Clearance of the hyaluronic acid (HA) based patch component joins the 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 patches1, and supports regenerative healing through improved cell infiltration1, tissue remodeling1, and tendon thickening. The Integrity Implant System is comprised of the HA-based patch implant, fixation implants, and single use arthroscopic delivery instruments.

The patch component of the system is a porous, flexible construct knitted using HYAFF® fibers and designed to support cell infiltration and regenerative healing. HYAFF is Anika?s proven and proprietary esterified HA technology that resorbs over time as tissue remodels. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears.

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. In an independent head-to-head animal study comparing Anika?s Integrity system and the leading competitive collagen device, fibroblast infiltration and regularly oriented new collagenous tissue formation had occurred within the Integrity repair, demonstrating greater regenerative capacity as early as 12 weeks post-implantation.

At 26 weeks, within the resorbing Integrity structure, new collagenous tissue infiltration forming a new network of tendon tissue had occurred. This resulted in the repaired tendon thickness being nearly 3 times greater than with the competitive collagen device. Tendon thickness is thought to improve the local biomechanical environment of the tear by reducing tendon strain, thus optimizing it?s healing potential.

The Integrity Implant System continues Anika?s focus on delivering new, differentiated shoulder solutions, with a specific focus on the intersection of regenerative solutions and sports medicine. The Integrity clearance, and upcoming launch, continues Anika?s release of unique products to support shoulder surgeons and a portfolio built around rotator cuff disease. Recent launches include Tactoset with hardware augmentation and with bone marrow aspirate, the X-Twist suture anchor fixation system, and the RevoMotion Reverse Shoulder System.

These new products allow Anika to expand deeper into the shoulder market by offering regenerative, sports medicine, and reconstructive solutions. Anika expects to commence a limited market release of Integrity in the United States in the first quarter of 2024 with a full U.S. market release and expansion into international markets to follow.