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.
*based on in vivo testing
- 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].
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
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