Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. At two years, subjects who received the BEAR implant had a laxity that, on average, was greater by 1.7 mm (about the same as the thickness of a penny) in the treated knee than that of the untreated knee. -, Andernord D, Desai N, Bjornsson H, Ylander M, Karlsson J, Samuelsson K. Patient predictors of early revision surgery after anterior cruciate ligament reconstruction: a cohort study of 16,930 patients with 2-year follow-up. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). Published Dec. 17, 2020 Greg Slabodkin Senior Editor Courtesy of Miach Orthopaedics Dive Brief: FDA has authorized a resorbable implant under the De Novo premarket review pathway that fills the gap between the torn ends of a patient's anterior cruciate ligament (ACL), one of the most common knee injuries in the U.S. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction (ACLR) group at 24 months shows an intact graft between the femoral and tibial tunnels (arrows). On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. February 2022. doi:10.1177/23259671211070542. . One of the most important findings of her research is that performing an ACL repair is very difficult, and it explains why initial attempts in the 1970's and 1980's did not work . J Transl Med. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. About Miach Orthopaedics, Inc. How many patients fail the BEAR implant and still need ACL reconstruction surgery? Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. Surgery can be tailored accordingly. Am J Sports Med. Despite being a very common injury, until today, the only surgical treatment available for torn ACLs has been ACL reconstruction using allograft, autograft or suture-only repair. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. Anterior Cruciate Ligament Repair: The Current Status : JBJS - LWW
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