New data shows Smith+Nephew's NOVOSTITCH™ Meniscal Repair Systems achieve 82.6% success rate for difficult to repair¹ horizontal cleavage tears at two years follow-up

Rhea-AI Summary

Smith+Nephew (NYSE:SNN) announced positive two-year follow-up results from the STITCH Study for its NOVOSTITCH Meniscal Repair Systems. This first-of-its-kind trial demonstrated an impressive clinical success rate of 82.6%, with significant improvements in all Patient Reported Outcome Measures (PROMs) at p<0.001. Complete meniscal healing was observed in 100% of patients evaluated at six months. The study emphasizes a shift towards meniscal repair, which could prevent long-term complications like osteoarthritis associated with meniscectomy. The NOVOSTITCH system offers innovative solutions for complex meniscal tears.

Positive

• 82.6% clinical success rate at two years
• 100% complete meniscal healing observed at six months
• Statistically significant PROM improvements (p<0.001)
• Potential paradigm shift in meniscal tear treatment towards repair

Negative

• None.

LONDON, Nov. 17, 2020 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, is pleased to announce the conclusion of and successful two-year follow-up results from the STITCH Study for its novel NOVOSTITCH Meniscal Repair Systems. The two-year results make a compelling case for surgeons to consider repairing the meniscus versus removing it.

The STITCH Study is the first of its kind, prospective clinical trial to evaluate the effectiveness of repairing Horizontal Cleavage Tears (HCTs), one of the most common meniscal tears.² Of the 1.2 million tears that occur annually in the US, nearly 80% are treated by partial resection,^3,4 also known as meniscectomy, which may put the patient at risk for adverse changes to the knee joint by leaving them open to osteoarthritis or total knee replacement later in life.^{5, 6} 

The two-year results of the study demonstrated:

1. A clinical success rate of 82.6%⁷
2. Statistically significant improvements in all Patient Reported Outcome Measures (PROMs) from baseline to two years (p<0.001)⁷
3. Complete meniscal healing (no visible defect) in 100% of patients undergoing needle arthroscopy at six months (11/11)⁷

"These results from the STITCH study set a new standard for outcomes in meniscal repair," said Dr. David Flanigan, Director of the Cartilage Restoration Program at The Ohio State University Wexner Medical Center and co-author of the STITCH Study. "Over two years of follow-up, the NOVOSTITCH Meniscal Repair System now presents an opportunity for a paradigm shift in the treatment of meniscal tears from meniscectomy to repair," Flanigan further commented.

Smith+Nephew's NOVOSTITCH Meniscal Repair System addresses challenging meniscal tear patterns not adequately served by other repair systems. By enabling surgeons to place stitches arthroscopically in tight joint compartments, NOVOSTITCH utilizes an all-inside, all-suture meniscus-to-meniscus circumferential compression stitch allowing repair of challenging meniscal tears. The system includes an ergonomic handle design, well-defined visual cues for precise stitch placement, and control and stability for accurate suture placement.

STITCH Study Principal Investigator and orthopaedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group, commented, "I'm gratified by the final results of the STITCH study. Two-year data is compelling and indicate that HCT's can and should be repaired when possible. The NOVOSTITCH™ Meniscal Repair System is now proven to be an effective tool capable of expanding meniscal repair for tears that have been considered irreparable, up until now."

"The STITCH Study represents a landmark achievement for Smith+Nephew by defining our commitment to drive the science behind meniscal repair and elevate the standard of care," stated Scott Schaffner, SVP of Global Marketing and US Commercial, Sports Medicine at Smith+Nephew. "Our goal is to get surgeons to think repair first – not removal."

The NOVOSTITCH™ PRO Meniscal Repair System - available in the US, Europe and other select countries - complements Smith+Nephew's leading All Tears, All Repairs meniscal repair portfolio. To learn more about the portfolio and the NOVOSTITCH PRO Meniscal Repair System please visit: http://www.AllTearsAllRepairs.com 

References

1. Kurzweil PR, Lynch, NM, Coleman S, Kearney B. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014;30(11):1513-1519
2. Metcalf MH, Barrett GR. Prospective Evaluation of 1485 Meniscal Tear Patterns in Patients with Stable Knees. AJSM. 2004;32(3):675-680
3. Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in Meniscus Repair and Meniscectomy in the United States, 2005-2011
4. 2018 SmartTRAK US Meniscal Repair Fixation market report
5. Beamer et al. Changes in Contact Area in Meniscus Horizontal Cleavage Tears Subjected to Repair and Resection. JARS.2017;33(3):617-624
6. Papalia R, Del Buono A, Osti L, Denaro V, Maffulli N. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin 2011;99:89-106
7. STITCH two year clinical study report: Kurzweil P, et al. (2020)

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 Twitter, LinkedIn, Instagram 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.

™ Trademark of Smith+Nephew. Certain marks registered US Patent and Trademark Office.

©2020 Smith+Nephew. All rights reserved.

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/new-data-shows-smithnephews-novostitch-meniscal-repair-systems-achieve-82-6-success-rate-for-difficult-to-repair-horizontal-cleavage-tears-at-two-years-follow-up-301174430.html

SOURCE Smith & Nephew plc