Scroll down and select the appropriate advisory committee meeting link. Meniscal substitution, a developing and long-awaited demand The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. Active Implants Enters Partnership with Geistlich Pharma AG for Contact us today for more information about the NUsurface Meniscus Implant. Can Manufacturing Technology Enhance Healthcare? The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 27, 2023. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. "Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement." The implant is made from a medical grade plastic called, polycarbonate-urethane. And, in case the implant doesnt fit the patient, which very rarely happens, it can be taken out and the knee is back to the same situation as before the implantation.. FDA's breakthrough devices program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. The NUsurfacemeniscus implant is the first artificial meniscus to be marketed in Europe and, if cleared by FDA, would be the first artificial meniscus in the United States, according to Active Implants. Two clinical trials are scheduled in the United States right now. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. NUsurface - Rimoni Industries Following these measures, the person has had to wait until the cartilage has deteriorated severely to the point where the knee needs to be replaced with an artificial implant made of metal and plastic. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' The medial meniscus replacement mimics the . 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, American Academy of Orthopedic Surgeons Annua, Society for Arthroscopy and Joint Surgery / G, 6060 Primacy Parkway Suite 460 Memphis, TN 38119, The Ohio State University Wexner Medical Center, https://clinicaltrials.gov/show/NCT02108496. Lines and paragraphs break automatically. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery.
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