Integrity

The Integrity™ Implant System is comprised of a hyaluronic acid-based implant fixated using PEEK bone staples, resorbable PLGA tissue tacks, or suture fixation, as desired, at the site of the rotator cuff augmentation.

The Integrity Implant is a hyaluronic acid-based scaffold intended for rotator cuff repair, Achilles repair, and other tendon repair applications. It is a porous, knitted scaffold constructed of Hyaff^® material, a proven hyaluronic acid technology that supports tissue regeneration and resorbs over time, reinforced with non-absorbable PET (polyethylene terephthalate).

Key Features & Benefits

Reliable strength

• Integrity provides higher tensile strength, suture retention, and tear resistance in a thin knitted format¹
• Inherently strong scaffold can be confidently manipulated arthroscopically and enables surgical versatility

Regenerative biology

• Hyaluronic acid-based scaffold supports regenerative healing through improved cell infiltration, tissue remodeling, and tendon thickening
• Porous, flexible construct knitted using Hyaff, Anika’s proven solid esterified hyaluronic acid technology that resorbs over time as tissue remodels

Streamlined technique for rotator cuff repair

• “Lateral first” fixation, unique instrumentation, and simplified surgical technique allow for precise implant placement
• Delivery instruments are single use and provided sterile for added efficiency

Foot & Ankle applications

• Achilles tendon
• Peroneal tendon
• Posterior tibialis tendon

Pre-clinical data

In a head-to-head pre-clinical study comparing Anika’s Integrity Implant and REGENETEN^®, results showed:

• As early as 12 weeks post-implantation, fibroblast infiltration and regularly oriented new collagenous tissue formation had occurred within the Integrity repair, demonstrating greater regenerative capacity compared to REGENETEN¹
• At 26 weeks, within the resorbing Integrity structure, new collagenous tissue infiltration forming a new network of tendon tissue had occurred, resulting in nearly 3 times greater thickness in the repaired tendon than REGENETEN¹
• Increased tendon thickness is thought to improve the local biomechanical environment of the tear by reducing tendon strain, thus optimizing its healing potential²