Smith + Nephew Launches FAST-FIX ™ FLEX Meniscal Repair System; expands all-interior repair possibilities with better access to all areas of the meniscus *
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, âFAST-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
âFAST-FIX FLEX will revolutionize the all-interior meniscal repair device segment,â said Dr. Jorge Chahla, Midwest Orthopedics in Rush, Chicago IL. âBy 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
âThe 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,â commented Christie Van Geffen, vice president of global marketing, joint repair, Smith + Nephew. âIts 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
- Smith + Nephew 2021.Validation, FAST-FIX FLEX. Internal report. 15010267 Rev. AT.
- Smith + Nephew 2021.Validation, FAST-FIX FLEX. Attachment B. Internal report. 15010267 Rev. AT.
- Smith + Nephew 2021.FAST-FIX FLEX – Surgeon Surveys. Internal memo.
- 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.
- 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.
- SmartTRAK US Meniscal Repair Fixation Market Report 2020.
- Smith + Nephew 2021. FAST-FIX FLEX competitive dimensional analysis. Internal report. 15010919 Rev. AT.
- Smith + Nephew 2020. Biomechanical testing, FAST-FIX FLEX. Internal report. 15010180 Rev. AT.
- 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.
- 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.
- 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.
- 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.
- Pengas IP, Assiotis A, Nash W. et al. Total meniscectomy in adolescents: a 40-year follow-up. JBJS 2012; 94-B: 1649-54
- Stein T, Mehling AP, Welsch F, von Eisenhart-Rothe R, JÃ¤ger 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
- 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 âLife Unlimitedâ. 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.
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