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Smith+Nephew REGENETEN Bioinductive Implant New Study

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Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, today announces study results showing patients treated with just its REGENETEN Bioinductive Implant for partial-thickness rotator cuff tears (>3mm) experienced significantly improved shoulder function during early recovery compared to patients receiving a REGENETEN Implant plus traditional surgical repair, with equivalent efficacy at one year.1

Presented at the AOSSM-AANA Combined 2021 Annual Meeting, study investigators compared the use of a REGENETEN Implant alone (without surgical repair) to a REGENETEN Implant plus traditional surgical repair for the treatment of partial-thickness rotator cuff tears in 227 patients across 19 US surgical centers.

Key findings of the study included:

  • Compared with traditional surgical repair, patients reported a significant improvement in shoulder function in the early post-operative period (weeks 2 and 6) with the REGENETEN Implant alone
  • Treatment with the REGENETEN Implant alone demonstrated equivalent efficacy to REGENETEN plus traditional surgical repair with minimal revisions across both treatment groups at 1 year
  • Among all patients receiving a REGENETEN Implant, patients reported significant improvements in pain, function and quality of life from at 1 year compared with pre-surgery values

“The results of this pioneering study show that using REGENETEN alone simplifies the surgical procedure. It is less invasive and can potentially lower risk of complications when compared with the current standard of care,” said Dr. Brad Bushnell, Chairman of the Orthopedic Department at the Harbin Clinic. “Using REGENETEN alone gives my patients the best chance for a quicker recovery with less pain and greater function.”

Smith+Nephew’s collagen-based REGENETEN Bioinductive Implant supports the body’s natural healing response by inducing the growth of new tendon-like tissue2-5 to biologically augment the existing tendon and disrupt disease progression.2-6 Delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, the implant is about the size of a postage stamp and is completely resorbed within six months.*4,7

“Since its introduction in 2014, the REGENETEN Implant has had a transformative impact on the way surgeons approach rotator cuff procedures,” said Scott Schaffner, SVP and GM, Global Sports Medicine, Smith+Nephew. “As access to the REGENETEN Implant expands and we continue to gather data, we’re excited to learn about the short and longer-term benefits it delivers to patients to help them live their life unlimited.”

Smith+Nephew’s REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide.

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


References

  1. Bushnell BD, et al. Treatment of partial-thickness rotator cuff tear repairs with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multi-center registry. Presented at: AOSSM-AANA Combined 2021 Annual Meeting, July 7-11, Nashville, Tennessee.
  2. Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J. 2016;6(1):16-25.
  3. Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251.
  4. Van Kampen C, Arnoczky S, Parks P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles Ligaments Tendons J. 2013;3(3):229-235.
  5. Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J. 2019;9(3):338-347.
  6. McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500.
  7. Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283
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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
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