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 knees1,2,5 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 meniscus6,10,11 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
- Smith+Nephew 2021.Validation, FAST-FIX FLEX. Internal Report. 15010267 Rev A.
- Smith+Nephew 2021.Validation, FAST-FIX FLEX. Attachment B. Internal Report. 15010267 Rev A.
- Smith+Nephew 2021.FAST-FIX FLEX- Surgeon Surveys. Internal Memo.
- 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.
- 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.
- 2020 SmartTRAK US Meniscal Repair Fixation market report.
- Smith+Nephew 2021. Competitive, FAST-FIX FLEX Dimensional Analysis. Internal Report. 15010919 Rev A.
- Smith+Nephew 2020. Biomechanical Testing, FAST-FIX FLEX. Internal Report. 15010180 Rev A.
- 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 the 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 knee osteoarthritis: 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, 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
- 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.
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.
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