Sports Medicine

New study shows 96% healing of hard to treat large and massive rotator cuff tears with Smith+Nephew’s REGENETEN™ Bioinductive Implant

LONDON, Nov. 19, 2019 /PRNewswire/ — Smith+Nephew (LSE: SN,NYSE: SNN), the global medical technology business, today announces a new clinical study illustrating the successful treatment of large (3-5cm) and massive (5cm+) rotator cuff tears using its REGENETEN Bioinductive Implant.1

Repairs of large and massive rotator cuff tears are recognised as having a high rate of failure, with more than 40% requiring further treatment2-4. The prospective, non-comparative arm study of the REGENETEN implant in 23 patients with large and massive tears in the US, published in the American Journal of Sports Medicine, demonstrated a 96% tendon healing rate at two years. There was no significant difference in treatment success between primary repairs and revision surgery.

“This study provides further insight into the success of the REGENETEN Bioinductive Implant,” said Michael O’Brien MD, Associate Professor of Clinical Orthopaedics, Tulane University School of Medicine, New Orleans, LA. “It is the latest addition to the growing body of evidence supporting REGENETEN as an effective treatment option that now covers the entire spectrum of tears from partial to large and massive tears.”

The collagen-based REGENETEN Bioinductive Implant stimulates the body’s natural healing response by inducing the growth of new tendon-like tissue to biologically augment the existing tendon and disrupt disease progression5-7. The REGENETEN implant, delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury, is about the size of a postage stamp and is gradually absorbed within 6 months.7*  

Tendon healing was assessed by serial ultrasound examinations to 24 months and a single post-operative MRI. Tendon thickness increased from 3 months to 12 months before slightly decreasing at 24 months, representing functional remodelling of the new tissue. No implant-related adverse events occurred.1

The REGENETEN implant’s efficacy in patients with partial-thickness and small full-thickness tears is well-known with data showing rapid and sustained healing including a reduced tear size in 94% of partial-thickness tear patients5 and no re-tears at 24 months in small full-thickness tears.8

“REGENETEN is the first solution of its kind to treat large and massive thickness rotator cuff tears,” said Vasant Padmanabhan, President of R&D, Smith+Nephew. “More than 650,000 rotator cuff procedures take place annually in the US, potentially growing at a rate of 5-6% each year. This data reinforces our confidence that this revolutionary technology is truly a game-changer in the treatment of patients with rotator cuff disease.”

The REGENETEN Bioinductive Implant is currently available in the United States.

References

  1. Thon SG, O’Malley L, O’Brien MJ, Savoie FH. Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes. Am J Sports Med. 2019 May 31. [Epub ahead of print].
  2. Bishop J, Klepps S, Lo IK, Bird J, Gladstone JN, Flatow EL. Cuff integrity after arthroscopic versus open rotator cuff repair: A prospective study. J Shoulder Elbow Surg. 2006;15(3):290-299.
  3. Heuberer PR,  Smolen  D,  Pauzenberger  L  et  al.  Longitudinal  long-term  magnetic  resonance  imaging  and  clinical  follow-up  after  single-row  arthroscopic  rotator  cuff  repair. Am  J  Sports  Med.  2017;45(6):1283-1288.
  4. Henry  P, Wasserstein D, Park S, et al. Arthroscopic repair for chronic massive rotator cuff tears: A systematic review. Arthroscopy. 2015;31(12):2472-80.
  5. 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. 2017.
  6. 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. MLTJ. 2016;6(1):16-25.
  7. Van Kampen C, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: A histological evaluation in sheep. MLTJ. 2013;3:229-235.
  8. Bokor DJ, Sonnabend D, Deady L, et al. Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up. Muscles Ligaments Tendons J. 2015;5(3):144-150.

*based on in vivo testing

About Smith+Nephew
Smith+Nephew is a portfolio medical technology business that exists to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 16,000+ employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT. Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $4.9 billion in 2018. Smith+Nephew is a constituent of the FTSE100 (LSE:SN,NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on TwitterLinkedInInstagram or Facebook.

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew’s expectations.

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SOURCE Smith+Nephew

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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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