FDA Clears Anika’s Integrity Implant System

Anika Therapeutics Inc. has received U.S. Food and Drug Administration 510(k) clearance for the Integrity Implant System, designed to augment an injured tendon in rotator cuff repair procedures.

Clearance of the hyaluronic acid (HA)-based patch component joins the prior FDA 510(k) clearances 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,¹ and supports regenerative healing through improved cell infiltration,¹ tissue remodeling,¹ and tendon thickening.¹
 
“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,” Anika Therapeutics President/CEO Cheryl R. Blanchard, Ph.D., said. “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, rotator cuff repair solution. This clearance opens significant opportunities in the shoulder and we see future expansion for this technology in other anatomies. Integrity enhances the breadth and depth of our regenerative offering, adding critical mass to a portfolio that provides solutions to unmet needs in early intervention orthopedics.”
 
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 strong and can be confidently manipulated arthroscopically, which offers a 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.
 
“I’m excited to see Anika working to improve the biologic augmentation market starting with rotator cuff repair. While some collagen products on the market are showing promising results with biological incorporation, in animal studies, Integrity facilitated improved biological healing without the use of animal collagen, while also providing a scaffold that can add strength to the construct at the time of implantation,” said Christopher Baker, M.D., of the Florida Orthopedic Institute. “In addition to improving the patch itself, they have also identified a more streamlined surgical technique. This product could improve patient outcomes and reduce the likelihood of future failures of rotator cuff repair.”
 
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 three 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.³
 
“Building on previous work with biological augmentation, the new Integrity system will be the next step forward in improving tendon healing and patient outcomes, with refined and more precise delivery. With the ability to augment and improve tendon healing along with increased structural support for early tendon repairs, Integrity should be the next big advance in improving patient outcomes in rotator cuff disease,” stated Timothy Codd, M.D., of the University of Maryland St. Joseph Medical Center.
 
The U.S. rotator cuff augmentation market is currently estimated at $150 million,² growing at a nearly 7% annually² over the next five years. The Integrity Implant System continues Anika’s focus on the intersection of regenerative solutions and sports medicine. 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 start a limited U.S. market release of Integrity in the first quarter next year, and follow with a full U.S. market release and expansion into international markets.
 
Anika Therapeutics Inc. is a global joint preservation company that creates and delivers advancements in early intervention orthopedic care. Leveraging our core expertise in hyaluronic acid and implant solutions, the company provides minimally invasive products that restore active living for people. Focus areas include osteoarthritis pain management, regenerative solutions, sports medicine, and arthrosurface joint solutions. Anika’s global operations are headquartered outside of Boston.
 
References
¹ Data on File
² 2023 SmartTrak
³ Schlegal, T. F., M.D. (2017). Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: A prospective multicenter study. Journal of Shoulder and Elbow Surgery. https://doi.org/10.1016/j.jse.2017.08.023