Anika Therapeutics, a US-based provider of tissue protection, healing, and repair products, has received the US Food and Drug Administration 510(k) approval for its Integrity Implant System.
The Integrity system is a flexible, knitted, hyaluronic acid (HA)-based scaffold, intended to augment an injured tendon to promote healing in rotator cuff repair procedures.
The system comprises HA-based patch implant, fixation implants, and single use arthroscopic delivery instruments.
It is said to improve the strength and regenerative capacity, and supports regenerative healing through cell infiltration, tissue remodeling, and tendon thickening.
Anika intends to begin a limited market release of Integrity system in the US in the first quarter of 2024, followed by a full market release in the US, and into international markets.
Anika president and CEO Cheryl R Blanchard said: “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.
“Integrity, named for its structural integrity compared with first-generation collagen patches, is a key value driver for Anika and was developed internally using our proprietary HA technology that has demonstrated differentiated regenerative performance characteristics.
“The HA-based patch, together with the instrumentation and fixation, provide a seamless, efficient, and elegant rotator cuff repair solution.”
Anika said that its Integrity system is inherently strong and provides a unique and differentiated solution for shoulder surgeons to treat rotator cuff tears.
Its patch component is made of a porous, flexible construct knitted with HYAFF fibers, to support cell infiltration and regenerative healing.
HYAFF is the company’s unique esterified HA technology that resorbs over time as tissue remodels.
The 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.
In an independent head-to-head animal study, Integrity system resulted in fibroblast infiltration and regularly oriented new collagenous tissue formation, with enhanced regenerative capacity.
Anika said that the implant system continues to focus on delivering new, differentiated shoulder solutions, with a specific focus on the intersection of regenerative solutions and sports medicine.
Blanchard added: “This clearance opens significant opportunities in the shoulder, and we see future expansion for this innovative technology in other anatomies.
“Integrity enhances the breadth and depth of our regenerative offering, adding critical mass to a growing portfolio that provides meaningful solutions to unmet needs in early intervention orthopedics that restore active living for patients around the world.”
