Smith+Nephew launches the FAST-FIX™ FLEX Meniscal Repair System; extends all-inside repair possibilities with greater access across all zones of the meniscus*

LONDON, July 7, 2021 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announces the launch of its FAST-FIX FLEX Meniscal Repair System, the only device to offer a surgeon-guided, bendable needle and shaft providing access to all zones of the meniscus. Improving access leads to a greater opportunity to repair the meniscus rather than remove it, resulting in long-term benefits to the patient.^{1-3, 13-15}

Building on the 15-year clinical legacy of its FAST-FIX platform, Smith+Nephew’s new FAST-FIX FLEX system uses an all-inside approach which may eliminate the need for further incisions, reduce the risk of neurovascular injury, and provide procedural efficiency to support faster operating times.⁴ The added ability to bend both the needle and shaft enables surgeons access to the mid-body and anterior zones, inaccessible by previous FAST-FIX devices. These meniscal zones account for more than 40% of tears in stable adult knees^1,2,5 or roughly 400,000 procedures, (meniscal repairs and meniscectomies) per year in the US alone.⁶

Dr. Jeffrey Klauser, Connecticut Orthopaedics commented, “FAST-FIX FLEX is a patient and surgeon friendly device that simplifies the all-inside approach. The ability to personalize the degree of curvature to the patient’s tear pattern eliminates the need to change portals or utilize multiple techniques while preserving meniscal tissue during repair.”

With one of the smallest needles in the all-inside device category and smooth, low-profile anchors, FAST-FIX FLEX offers a 25% reduction in needle insertion area as well as a repair that is more than 20% stronger than the previous generation FAST-FIX 360 System.^**7,8

“FAST-FIX FLEX will revolutionize the all-inside meniscal repair device segment,” said Dr. Jorge Chahla, Midwest Orthopaedics at Rush, Chicago IL. “Delivering characteristics of FAST-FIX 360, the gold standard in meniscal repair, FLEX adds new features enabling surgeons to address previously inaccessible tears through the quick and reproducible all-inside approach; while improving upon the tried and true technique.”

Meniscal tears continue to be one of the most common orthopaedic injuries.⁹ To treat this injury, most patients receive a partial meniscectomy or a complete removal of the meniscus^6,10,11 shown to significantly increase the risk of osteoarthritis and the rate to total knee replacement.^12,13,14 Alternatively, meniscal repair, has been shown to slow the progression of osteoarthritis which may facilitate a quicker return to normal knee function post injury.^13,14,15

“The launch of FAST-FIX FLEX represents a new milestone in meniscal repair, and we are truly delighted to provide this technology to surgeons across the globe,” commented Christie Van Geffen, Vice President Global Marketing, Joint Repair, Smith+Nephew. “Its addition to our All Tears, All Repairs Meniscal Repair Solutions portfolio will accelerate our goal to change the standard of care away from meniscectomy and toward meniscal repair.”

The FAST-FIX FLEX Meniscal Repair System is commercially available for sale in the US and select countries across the globe. For more information, please visit: https://www.smith-nephew.com/key-products/sports-medicine/fastfix-flex/

^*As compared to predicate device
^**As demonstrated in biomechanical testing

References

1. Smith+Nephew 2021.Validation, FAST-FIX FLEX. Internal Report. 15010267 Rev A.
2. Smith+Nephew 2021.Validation, FAST-FIX FLEX. Attachment B. Internal Report. 15010267 Rev A.
3. Smith+Nephew 2021.FAST-FIX FLEX- Surgeon Surveys. Internal Memo.
4. Karia M, Youssef G, Al-Hadithy N, Mordecai S, Gupte C. Current concepts in the techniques, indications and outcomes of meniscal tears. Eur J Orthop Surg Traumatol. 2019;29(3):509-520.
5. Metcalf MH, Barrett GR. Prospective evaluation of 1485 meniscal tear patterns in patients with stable knees. Am J Sports Med. 2004;32(3):675-680.
6. 2020 SmartTRAK US Meniscal Repair Fixation market report.
7. Smith+Nephew 2021. Competitive, FAST-FIX FLEX Dimensional Analysis. Internal Report. 15010919 Rev A.
8. Smith+Nephew 2020. Biomechanical Testing, FAST-FIX FLEX. Internal Report. 15010180 Rev A.
9. Mordecai SC, Al-Hadithy N, Ware HE, Gupte CM. Treatment of meniscal tears: An evidence based approach. World Journal of Orthopedics 2014;5(3):233-241.
10. Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in Meniscus Repair and Meniscectomy in the United States, 2005-2011. AJSM 2013;41(10):2333-9.
11. Katano H, Koga H, Ozeki N, et al. Trends in isolated meniscus repair and meniscectomy in Japan, 2011-2016, Int. J. Orthop Sci. 2018;23(4):678-81.
12. Papalia R, Del AD, Osti L, Denaro V. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011;99:89-106.
13. Pengas IP, Assiotis A, Nash W. et al. Total Meniscectomy in Adolescents: A 40 Year Follow-up. JBJS 2012;94-B:1649-54
14. Stein T, Mehling AP, Welsch F, von Eisenhart-Rothe R, Jäger A. Long-term outcome after arthroscopic meniscal repair versus arthroscopic partial meniscectomy for traumatic meniscal tears. Am J Sports Med. 2010;38(8):1542-1548
15. Lee, WQ, Gan JZW, Lie, TTD. Save the meniscus- Clinical outcomes of meniscectomy versus meniscal repair. Journal of Orthopaedic Surgery. 2019;27(2):1-6.

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 18,000 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 $4.6 billion in 2020. 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: risks related to the impact of COVID-19, such as the depth and longevity of its impact, government actions and other restrictive measures taken in response, material delays and cancellations of elective procedures, reduced procedure capacity at medical facilities, restricted access for sales representatives to medical facilities, or our ability to execute business continuity plans as a result of COVID-19; economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers (including, without limitation, as a result of COVID-19); 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 (including, without limitation, as a result of COVID-19); 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.

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