SPORTS MEDICINE

REGENETEN◊ Bioinductive Implant

Supports rotator cuff tendon-like tissue growth, 1,2,4,5 and shown to reduce the risk and incidence of re-tears following full-thickness tear repairs12

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Redefining biological healing

Supports the body’s natural healing response to facilitate new tendon-like tissue growth and changes the course of rotator cuff tear progression.2-6

Comprised of type 1 collagen,7 it's an advanced healing solution for biological tendon regeneration for the entire spectrum of disease, from partial-thickness to massive rotator cuff tears.1-6,8

Limiting the impact of re-tears

When rotator cuff re-tears can impose a substantial burden on patients and practices, a randomized controlled trial concluded that adding a REGENETEN Implant (n=60) to the repair of full-thickness tears resulted in (compared to standard repairs alone, n=62):

  • Risk of re-tear three times lower (8.3% vs 25.8%; RR=0.32; [95% CI: 0.13-0.83]; p=0.0106)12
  • Better tendon integrity Difference in Sugaya grade between groups, (p=0.030)12
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Disclaimer

*Finite element analysis indicated that the addition of 2 mm of tendinous tissue on the bursal side of a supraspinatus tendon with an articular-sided tear reduced the peak strain at the site of the tear by 40%.

**On human biopsy (n=1) and in-vivo sampling.

***Patients with partial thickness tears; 3 to 12 months n=46, 2 year n=13, 5 years n=11.

****Demonstrated in a study of patients with partial-thickness tears.

*****Demonstrated in patients with partial and full-thickness tears, compared to pre-operative values; p≤0.015.

Citations
  1. Thon SG, et al. Am J Sports Med. 2019;47(8):1901-1908.
  2. Van Kampen C, et al. Muscles Ligaments Tendons J. 2013;3(3):229-235.
  3. Bokor DJ, et al. MLTJ. 2019;9(3):338-347.
  4. Schlegel TF, et al. J Shoulder Elbow Surg 2017;27(2):242-251.
  5. Bokor DJ, et al. Muscles, Ligaments Tendons J 2016;6(1):16-25.
  6. McElvany MD, et al. Am J Sports Med. 2015;43(2):491-500.
  7. Smith+Nephew 2020. Internal report. REGENETEN Collagen Implant Physical Characteristics.
  8. McIntyre LF, et al. Arthroscopy. 2019 July 23.
  9. Material and Structural Testing Core, Mayo Clinic 2019. Internal report. EO/SPM/REGENTEN/001/V1.
  10. Arnoczky SP, et al. Arthroscopy. 2017;33(2):278-283.
  11. Schlegel TF, et al. JSES. 2021;30(8):1938-48.
  12. Ruiz-Ibán MA, et al. Arthroscopy. Published online December 27, 2023.

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