Integrity<sup>™</sup> Implant System

Integrity Implant System

An HA-Based Scaffold for Rotator Cuff and Other Tendon Repair

Integrity<sup>™</sup> Implant System

What Is Integrity?

The Integrity™ Implant is a hyaluronic acid (HA)-based scaffold for tendon repair that provides reliable strength and regenerative biology. The implant is a porous, knitted scaffold constructed from Hyaff®, our proprietary HA fiber, that supports tissue regeneration, resorbs over time, and is reinforced with PET (polyethylene terephthalate), a permanent material commonly used in sutures that is well known for its biostability and promotion of tissue ingrowth.1 By utilizing both Hyaff and PET, Integrity is a unique hybrid structure that offers biologic enhancement and strength for confident implantation.

Integrity is available in multiple shapes and sizes, 20x25mm, 25x30mm, 25x60mm, and 40x60mm, all of which are 80% Hyaff and 20% PET. The wide range of available sizes offers intra-operative flexibility, supporting a broad spectrum of tendon repair procedures in the shoulder, knee, hip, foot, and ankle.

Rotator Cuff tendon
full thickness and partial thickness tears
Anatomical cross-section showing Achilles tendon repair with surgical implant or device in the heel area.
Achilles tendon
Medical illustration showing a surgical clamp holding torn muscle tissue together on an arm for repair.
Peroneal tendon
Medical illustration showing a spinal cord stimulator implant device placed in the lower back area with connecting leads.
Gluteus medius tendon
Patellar tendon
Cross-sectional medical illustration showing knee surgery with surgical instruments and a red mesh implant being placed in the joint.
Quadriceps tendon

Real Life Advantages

Tendon augmentation is designed to support regenerative healing and thickening of tendons for a strong recovery. Integrity promotes tendon regeneration by incorporating hyaluronic acid, which enhances the body’s cellular response and supports the natural healing process.

Reliable strength

  • Integrity provides higher tensile strength, suture retention, and tear resistance in a thin knitted format, even when wet2
  • Inherently strong scaffold can be confidently manipulated arthroscopically and enables surgical versatility
Bar chart comparing Integrity vs REGENETEN across three strength measures, showing Integrity has nearly 50% greater tensile strength and over 3X suture retention and tear resistance.

Regenerative biology

  • Hyaluronic acid-based scaffold supports regenerative healing through improved cell infiltration, tissue remodeling, and tendon thickening3
  • Porous, flexible, knitted construct using Hyaff, Anika’s proven solid esterified HA technology that resorbs over time as tissue remodels2
Gloved hands holding a flexible electronic device with a grid pattern of blue sensors on a bendable surface.

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
Medical procedure kit containing various surgical instruments including syringes, tubes, clamps, and sterile packaging on white background.

The Science Behind Integrity

Integrity is a biologic scaffold engineered to meet the mechanical and biologic demands of tendon repair, leveraging hyaluronic acid to create a regenerative environment that supports tendon healing.4

Optimized Porosity for Cellular Infiltration

Integrity’s porous, knitted architecture facilitates cell infiltration and tissue ingrowth, promoting biologic integration with the native tendon3

Hyaluronic Acid (HA)-Based Composition

Comprised primarily of Hyaff, 100% esterified HA, Integrity provides a semi-resorbable scaffold that supports healing and enhances biocompatibility through HA’s natural role in tissue repair4,5

Reinforced with PET for Handling and Fixation

Non-absorbable PET fibers provide implant strength, allowing for enhanced intraoperative handling, precise manipulation, and reliable performance

Material Biocompatibility

With 80% resorbable Hyaff and 20% PET, Integrity is not a xenograft (a graft from another species), meaning it contains no animal tissues or byproducts

How It Works

Tendons are bands of connective tissue that attach muscles to bones, enabling movement. These bands, while flexible, can tear under sudden or prolonged repetitive stress. The severity of the injury can vary from micro-tears to the tendon being fully torn.

If tendon repair surgery is required, the Integrity Implant may be used to augment the repair. Integrity combines PET fibers for high tensile strength and durability with HA, adding biology to the tendon repair and providing a more natural healing environment that aids in tendon regeneration and healing.1-3

Placement

The Integrity Implant is placed over the tendon repair, often via minimally invasive arthroscopic surgery

Fixation

Integrity is fixated using bone staples, tendon tacks, or sutures for secure placement

Healing Process

During the healing process, Integrity promotes cell infiltration and tissue remodeling within its porous structure3

Resorption

The Hyaff portion of Integrity resorbs over time, allowing native tissue to replace the scaffold

Evidence

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 REGENETEN3
  • 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 REGENETEN3
  • Increased tendon thickness is thought to improve the local biomechanical environment of the tear by reducing tendon strain, thus optimizing its healing potential6

Clinical Highlights: Integrity Implant System for Rotator Cuff Repair7

A recent white paper evaluating 29 patients treated with the Integrity Implant System for partial and full thickness rotator cuff tears revealed compelling early outcomes:

  • Pain relief and functional improvement sustained over 6 months7
  • No device-related complications reported7
  • No evidence of retears at the 6-month follow-up7
The Integrity Implant System shows promise as a biologic strategy to support tendon healing in rotator cuff repair.2,3,7,8

The Integrity Implant System is available in the US and select markets outside of the United States and is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

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(opens in a new tab).

REGENETEN is a registered trademark of Smith+Nephew.

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