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FDA OKs Miach Orthopaedics' BEAR Implant for ACL Tears Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. This difference in injury risk is an important focus of research and has been attributed to anatomy, hormonal effects, neuromuscular control, biomechanics, and sport participation. . FDA authorizes marketing of ACL implant - Medical Xpress PMID: 23813800. effective surgery for ACL tears.17,23 The BEAR technique does not require the compromise of other healthy tissues around the knee, as is required with ACL reconstruction with an autograft. The request was submitted under section 513(f)(2) of the FD&C Act. 'Breakthrough' treatment for ACL tears allows tendon to heal - WTOP The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction. Bridge Enhanced ACL Restoration (BEAR Implant) eCollection 2023 Apr. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. Am J Sports Med. The ACL, a ligament located with the knee, is the tissue responsible for bridging the shinbone to the thigh bone. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Medical School, Harvard University or its affiliated academic health care centers, the NFL Players Association, Boston Childrens Hospital, or the NIH. Lower left panel: The free suture ends (green) at the tibial end of the BEAR implant (which was positioned between the 2 ends of the torn ACL) are passed through the tibial tunnel to be tied over a second extracortical button. Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. -. Upper right panel: After a cortical button carrying free sutures (green) is passed up through the femoral tunnel, the BEAR implant is loaded onto them and soaked with up to 10 mL of autologous blood. 8600 Rockville Pike Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function. B.L.P. This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant.