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PROCEDURES, INDICATIONS AND THERAPIES

Full-thickness rotator cuff tears

When a quarter of full-thickness rotator cuff repairs result in re-tear, augment repairs with the REGENETEN◊ Bioinductive Implant to help more repairs stay repaired.*1


Go to partial thickness tears
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Reduce your likelihood of re-tears

The REGENETEN Implant is a bioinductive scaffold made from highly purified type I collagen fibers.2 Following fixation using its efficient** and suture-free technique,1 the REGENETEN Implant is resorbed and replaced by a new layer of tendon-like tissue within 6 months3-6 increasing tendon thickness7-9 and creating an environment conducive to healing.3,8,9

A decade of clinical experience has demonstrated a meaningful impact on full-thickness repair outcomes.7,10

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Key features

Clinical studies have demonstrated the value of the REGENETEN Bioinductive Implant as an augment to repair:


Step 1: Biomechanical repair

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Rotator cuff repair with Advanced Healing Solutions starts with a unique biomechanical construct using open-architecture HEALICOIL◊ Suture Anchors, which may support the body’s natural healing response.11 Available with REGENESORB◊ Material, which is absorbed and effectively replaced by bone within 24 months.12



Step 2: REGENETEN insertion

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Apply the REGENETEN Implant over the biomechanical repair using the tendon and bone anchors provided; allowing the REGENETEN Implant to serve as a scaffold for new tendon-like tissue growth1,3,5,6 and increased tendon thickness.7-9



Step 3: How the REGENETEN Implant works

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By supporting the body's healing response,4-8 the REGENETEN Implant is replaced by an average 2mm of new tendon-like tissue within 6 months2-8 creating an environment conducive to tendon healing.4,7,8



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Evidence

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Supporting information

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Related products and pages




Disclaimers

* 8.3% vs 25.8% at 1 year. Relative risk=0.32 [95% Confidence Interval 0.13-0.83]; p=0.0106

** Mean 13.9 min addition to standard rotator cuff repair.

*** Difference in Sugaya grade between groups at 12 months; p=0.03.

**** In rotator cuff repair. Based on implant sales 2018-2024.




Citations
  1. Ruiz Ibán MÁ, et al. Arthroscopy. 2024;40(6):1760-1773.
  2. Smith+Nephew 2020. Internal Report. 15009769.
  3. Van Kampen C, et al. Muscles Ligaments Tendons J. 2013;3(3):229-235.
  4. Arnoczky SP, et al. Arthroscopy. 2017;33(2):278-283.
  5. Camacho Chacón JA, et al. J Shoulder Elbow Surg. 2024;33(9):1894-1904.
  6. Camacho-Chacon JA, et al. J Exp Orthop. 2022;9(1):53.
  7. Bokor DJ, et al. Muscles, Ligaments Tendons J. 2015;5(3):144-150.
  8. Bokor DJ, et al. Muscles Ligaments Tendons J. 2016;6(1):16-25.
  9. Schlegel TF, et al. J Shoulder Elbow Surg. 2018 27(2):242-251.
  10. Warren JR, et al. J Shoulder Elbow Surg. 2024;33(11):2515-2529.
  11. Chahla J, et al. Arthroscopy. 2020;36(4):952-961.
  12. Smith + Nephew 2016. Internal Report. NCS248.

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