Integrity

Implant System

The Integrity™ Implant System is comprised of an HA-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 implant 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.

Key Features & Benefits

  • Reliable strength – Material and knit structure provides higher tensile strength, suture retention, and tear resistance*
  • Regenerative biology – Hyaluronic acid scaffold supports healing through improved cell infiltration, tissue remodeling, and tendon thickening
  • Streamlined technique – “Lateral first” fixation, unique instrumentation, and simplified technique allow for precise placement
  • The delivery instruments are single use and provided sterile for added efficiency

In an independent head-to-head animal study, comparing Anika’s Integrity system and the leading competitive collagen device, results showed1:

  • Fibroblast infiltration and regularly oriented new collagenous tissue formation, demonstrating greater regenerative capacity as early as 12 weeks post-implantation.
  • At 26 weeks, new collagenous tissue infiltration forming a new network of tendon tissue had occurred. The repaired tendon thickness is nearly 3 times greater versus 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.2

The Integrity Implant System is available in the US only.

The Integrity Implant System is not available outside of the United States.

Anika products may not be available in all geographies. Product availability is subject to the regulatory clearances in individual markets. Please reach out to your local representative or Contact Us if you have questions about specific market approvals.

For complete product information, including indications, contraindications, warnings, and precautions, please refer to the Instructions for Use found here.

References

* Compared to the market-leading collagen implant

  1. Data on file, Anika Therapeutics, Inc.
  2. 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
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