New study confirms Smith+Nephew’s REGENETEN™ Bioinductive Implant
reduces full-thickness rotator cuff re-tear rates¹ by 68%
First published randomized controlled trial for
market-leading implant demonstrates impressive outcomes for rotator
cuff tears
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology
company, today announces standout results for its REGENETEN
Bioinductive Implant from a recently completed randomized
controlled trial (RCT). Published online in Arthroscopy in
December, the report concluded that at one-year, medium and large
full-thickness rotator cuff tears repaired and augmented with the
REGENETEN Bioinductive Implant had better tendon healing compared
to the standard of care,1 as evidenced by:
- A significantly lower re-tear rate (8.3 vs 25.8%; p=0.01)
- A three times lower risk of re-tear (RR=0.32; 95%
CI:0.13–0.83)
- No difference in the number of serious or minor
complications
The blinded, multi-centre RCT compared the healing rate of
full-thickness rotator cuff tears repaired with and without
augmentation with the REGENETEN Bioinductive Implant. In total, 124
patients with reparable medium and large (1–4cm) full-thickness
posterosuperior rotator cuff tears were randomized to receive
either an arthroscopic transosseous equivalent double-row rotator
cuff repair or the same repair augmented with the REGENETEN
Bioinductive Implant.
Dr. Miguel Ruiz Ibán, Head of the Shoulder and Elbow Unit at
Hospital Universitario Ramón y Cajal in Madrid, Spain, and
Principal Investigator for the study commented on the results,
“Rotator cuff repair is traditionally associated with re-tear rates
in excess of 20%, presenting a challenge for surgeons and patients
alike. This RCT demonstrates that the REGENETEN Bioinductive
Implant substantially and significantly reduced this risk. With no
increase in complications seen in our study, these findings support
the use of the implant to reduce re-tear rates in the population
studied.”
With more than 100,000 procedures completed globally since its
introduction in 2014, the REGENETEN Bioinductive Implant has had a
transformative impact, offering a better solution for more than 1
million2 people having surgery for a rotator cuff tear each year.
The collagen-based implant supports the body’s natural healing
response to facilitate the formation of new tendon-like tissue to
biologically augment the existing tendon and change the course of
rotator cuff tear progression.1,3-8
Smith+Nephew's REGENETEN Bioinductive
Implant
“Smith+Nephew is committed to proving the value of our
technology through support for clinical evidence generation,” said
Christie Van Geffen, SVP Sports Medicine Global Marketing at
Smith+Nephew. “We are pleased and excited by the opportunity
presented by this evidence to drive adoption of, and access to, the
REGENETEN Bioinductive Implant. Our goal is to help surgeons
improve the care of many more patients with rotator cuff
injuries.”
The REGENETEN Bioinductive Implant is part of Smith+Nephew’s
comprehensive Advanced Healing Solutions portfolio – redefining
biological healing in rotator cuff repair.
To learn more about the REGENETEN Bioinductive Implant, please
click here.
- ends -
Media Enquiries
David SnyderSmith+Nephew +1 978-749-1440
david.snyder@smith-nephew.com
References
- Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of
a transosseous equivalent repair in posterosuperior non-acute
rotator cuff tears with a bioinductive collagen implant decreases
the re-tear rate at one year. A randomised controlled trial.
Arthroscopy. Published online 12/27/2023.
- iData Research. Rotator cuff repair and reconstruction market
size, share and trends analysis (2023). Available at:
https://idataresearch.com/product/rotator-cuff-repair-reconstruction-market-size-share-and-trends-analysis-global-2023-2029-medsuite-includes-grafts-allografts-xenograft-synthetic-and-1-more/#.
Accessed December 19, 2023.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
About Smith+NephewSmith+Nephew is a portfolio
medical technology company focused on the repair, regeneration and
replacement of soft and hard tissue. We exist 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 19,000
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 business units of Orthopaedics, Sports
Medicine & ENT and Advanced Wound Management.
Founded in Hull, UK, in 1856, we now operate in more than 100
countries, and generated annual sales of $5.2 billion in 2022.
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
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Forward-looking StatementsThis 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
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its impact, government actions and other restrictive measures taken
in response, material delays and cancellations of elective
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especially those affecting healthcare providers, payers and
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price levels for established and innovative medical devices;
developments in medical technology; regulatory approvals,
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Smith+Nephew's REGENETEN Bioinductive Implant
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