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  • Smith + Nephew Launches FAST-FIX ™ FLEX Meniscal Repair System; expands all-interior repair possibilities with better access to all areas of the meniscus *

Smith + Nephew Launches FAST-FIX ™ FLEX Meniscal Repair System; expands all-interior repair possibilities with better access to all areas of the meniscus *

By on July 7, 2021 0


Building on the 15-year clinical legacy of its FAST-FIX platform, Smith + Nephew’s new FAST-FIX FLEX system uses an all-interior approach that can eliminate the need for additional incisions, reduce risk neurovascular injury and provide procedural efficiency to support faster uptime.4 The added ability to bend both the needle and the rod allows surgeons to access the midline and anterior areas of the body, inaccessible by previous FAST-FIX devices. These meniscal areas account for over 40% of tears in stable adult knees1,2,5 or about 400,000 procedures (meniscal repairs and meniscectomies) per year in the United States alone.6

Dr. Jeffrey Klauser, Connecticut Orthopedics commented, “FAST-FIX FLEX is a patient and surgeon friendly device that simplifies the all-interior approach. meniscal tissue during repair. ”

With one of the smallest needles in the all-interior device category and smooth, discreet anchors, FAST-FIX FLEX offers a 25% reduction in needle insertion area as well as more repair. 20% more resistant than the previous generation FAST-FIX 360 system.** 7.8

“FAST-FIX FLEX will revolutionize the all-interior meniscal repair device segment,” said Dr. Jorge Chahla, Midwest Orthopedics in Rush, Chicago IL. “By offering the features of FAST-FIX 360, the gold standard in meniscal repair, FLEX adds new features enabling surgeons to treat previously inaccessible tears with the fast and reproducible all-inside approach; while improving the proven technique. “

Meniscal tears continue to be one of the most common orthopedic injuries.9 To treat this injury, most patients undergo partial meniscectomy or complete meniscus removal.6.10.11 significantly increases the risk of osteoarthritis and the rate of total knee replacement.12.13.14 Alternatively, meniscal repair has been shown to slow the progression of osteoarthritis, which may facilitate a faster return to normal knee function after injury.13.14.15

“The launch of FAST-FIX FLEX represents a new milestone in meniscal repair, and we are truly excited to provide this technology to surgeons around the world,” commented Christie Van Geffen, vice president of global marketing, joint repair, Smith + Nephew. “Its addition to our portfolio of All Tears meniscal repair solutions, All Repairs will accelerate our goal of changing the standard of care from meniscectomy to meniscal repair. “

The FAST-FIX FLEX Meniscal Repair System is commercially available in the United States and some countries around the world. For more information, please visit: https://www.smith-nephew.com/key-products/sports-medicine/fastfix-flex/

*Compared to the predicate device
**As demonstrated in biomechanical tests

The references

  1. Smith + Nephew 2021.Validation, FAST-FIX FLEX. Internal report. 15010267 Rev. AT.
  2. Smith + Nephew 2021.Validation, FAST-FIX FLEX. Attachment B. Internal report. 15010267 Rev. AT.
  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 of 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. SmartTRAK US Meniscal Repair Fixation Market Report 2020.
  7. Smith + Nephew 2021. FAST-FIX FLEX competitive dimensional analysis. Internal report. 15010919 Rev. AT.
  8. Smith + Nephew 2020. Biomechanical testing, FAST-FIX FLEX. Internal report. 15010180 Rev. AT.
  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 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 osteoarthritis of the knee: 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 results 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 Results of Meniscectomy Versus Meniscal Repair. Journal of Orthopedic Surgery. 2019; 27 (2): 1-6.

About Smith + Neveu
Smith + Nephew is a portfolio medical technology company that exists to restore people’s bodies and self-confidence by using technology to push the boundaries of life. We call this goal “Life Unlimited”. Our 18,000 employees accomplish this mission every day, making a difference in the lives of patients through the excellence of our product portfolio, and the invention and application of new technologies in our three global orthopedics franchises. , advanced wound management, sports medicine and ENT.

Founded in Hull, United Kingdom, in 1856, we now operate in over 100 countries and generate annual sales of 4.6 billion dollars in 2020. Smith + Nephew is part 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 on Smith + Nephew, please visit www.smith-neveu.com and follow us on Twitter, LinkedIn, Instagram or Facebook.

Forward-looking statements
This document may contain forward-looking statements which may or may not prove to be correct. For example, statements regarding expected revenue growth and trading margins, market trends and our product portfolio 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 associated with the impact of COVID-19, such as the depth and longevity of its impact, government actions and other restrictive measures taken in response, significant delays and cancellations of elective procedures, reduced capacity of procedures at medical facilities, restricted access of sales representatives to medical facilities or our ability to execute business continuity plans due to COVID-19; economic and financial conditions in the markets we serve, particularly those affecting healthcare providers, payers and clients (including, without limitation, due to COVID-19); the price levels of 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 non-compliance with related regulations; disputes relating to patents 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, due to COVID-19); competition for qualified personnel; strategic actions, including acquisitions and divestitures, our success in exercising due diligence, valuation and integration of acquired businesses; disruptions that may result from transactions or other changes we make to our business plans or organization to adapt to changing market conditions; and many other matters that affect us or our markets, including those of a political, economic, commercial, competitive or reputational nature. Please see documents that Smith + Nephew has filed with the United States Securities and Exchange Commission under the US Securities Exchange Act of 1934, as amended, including Smith + Nephew’s most recent annual report on the Form 20-F, for a discussion of some of these factors. Any forward-looking statement is based on information available to Smith + Nephew at the date of the statement. All written or oral forward-looking statements attributable to Smith + Nephew are qualified by this cautionary statement. Smith + Nephew assumes no 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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