Regenerative Medicine

Integrity™ Implant System

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

1

What Is Integrity™?

Integrity™ is a hybrid tendon repair scaffold composed of:

  • 80% Hyaff® (esterified hyaluronic acid)
  • 20% PET fibers (polyethylene terephthalate)7,8

The hybrid design combines biologic support with mechanical reinforcement. The Hyaff scaffold supports cellular infiltration and tissue remodeling,4,5 while PET fibers provide durability and handling characteristics7 during implantation.

Available in multiple sizes to support shoulder, knee, hip, foot, and ankle tendon repairs.

Rotator Cuff Tendon Rotator Cuff Tendon
Achilles Tendon Achilles Tendon
Peroneal Tendon Peroneal Tendon
Gluteus Medius Tendon Gluteus Medius Tendon
Patellar Tendon Patellar Tendon
Quadriceps Tendon Quadriceps Tendon
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Why Choose Integrity™?

Tendon augmentation supports biologic healing and tendon remodeling following repair. Integrity incorporates hyaluronic acid technology to promote cellular infiltration and tissue regeneration.

Reliable Mechanical Strength

  • High tensile strength and suture retention7,8
  • Maintains structural integrity when hydrated8
  • Facilitates arthroscopic handling and fixation7,8
Integrity mechanical strength chart
Integrity biologic healing support

Biologic Healing Support

  • HA-based scaffold promotes cell infiltration1,4,5
  • Supports tissue remodeling and tendon thickening1,4,5
  • Gradually resorbs as healing progresses4,5

Procedural Simplicity

  • Streamlined implantation technique3
  • Precise scaffold placement3
  • Sterile, single-use delivery instruments3
Integrity delivery instruments
3

Engineered for Tendon Repair

Integrity™ combines key design features that support tendon repair:

FeatureClinical Relevance
Porous knitted architectureSupports cellular infiltration and tissue ingrowth1
Hyaff® technologyProvides a bioactive, resorbable scaffold4,5
PET reinforcementEnhances handling and mechanical strength7,8
Hybrid compositionBalances biologic healing with structural support2,8
Non-xenograft designContains no animal-derived tissue2,8

Following tendon repair, Integrity™ is positioned over the repair site as an augmentation scaffold.3 The PET component provides immediate structural support,7,8 while the Hyaff matrix promotes cellular infiltration and tissue remodeling.1,4,5 Over time, the Hyaff component gradually resorbs as new tendon tissue develops.4,5

Clinical Relevance

Placement
1
Placement
Placed over the tendon repair, often via minimally invasive arthroscopic surgery.
Fixation
2
Fixation
Fixated using bone staples, tendon tacks, or sutures for secure placement.
Healing Process
3
Healing Process
Promotes cell infiltration and tissue remodeling within its porous structure.
Resorption
4
Resorption
The Hyaff portion resorbs over time, allowing native tissue to replace the scaffold.
4

Evidence

In a head-to-head preclinical comparison with REGENETEN®:

  • Greater fibroblast infiltration observed as early as 12 weeks1
  • More organized collagen formation within the repair tissue1
  • Nearly 3× greater tendon thickness at 26 weeks1
  • Enhanced tissue remodeling within the resorbing scaffold1

Increased tendon thickness may contribute to a more favorable biomechanical environment and reduced tendon strain during healing.6

Clinical Highlights: Rotator Cuff Repair3

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 months3
  • No device-related complications reported3
  • No evidence of retears at the 6-month follow-up3

The Integrity Implant System shows promise as a biologic strategy to support tendon healing in rotator cuff repair.3

View Full White Paper

References

  1. Walsh WR, et al. Rotator Cuff Healing with Anika Technology. Data on File, Anika Therapeutics, Inc.
  2. Patel R, et al. Hyaluronic Acid–Biocompatible Implant System for Rotator Cuff Augmentation. Arthroscopy Techniques. 2025:103990.
  3. Porter DA, Pietrzak WS. The Integrity Implant System: Early Outcomes Following Rotator Cuff Repair. White Paper. Anika Therapeutics, Inc. 2025. AML-900-735 REV 01.
  4. Hu M, et al. Three-Dimensional Hyaluronic Acid Grafts Promote Healing and Reduce Scar Formation in Skin Incision Wounds. Journal of Biomedical Materials Research. 2003;67(1):586–592.
  5. Vindigni V. Hyaluronan Benzyl Ester as a Scaffold for Tissue Engineering. International Journal of Molecular Sciences. 2009;10:2972–2985. doi:10.3390/ijms10072972.
  6. Schlegel TF. Radiologic and Clinical Evaluation of a Bioabsorbable Collagen Implant to Treat Partial-Thickness Tears: A Prospective Multicenter Study. Journal of Shoulder and Elbow Surgery. 2017. doi:10.1016/j.jse.2017.08.023.
  7. Metzger A. Polyethylene Terephthalate and the Pillar™ Palatal Implant: Its Historical Usage and Durability in Medical Applications. Biomedical Engineering. 1976;11(9):301–306.
  8. Data on File. Anika Therapeutics, Inc.