The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . The NUsurface, which is the first artificial meniscus to be marketed in Europe, is currently being reviewed by the US Food and Drug Administration (FDA). +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " Before sharing sensitive information, make sure you're on a federal government site. The device is a polymeric disc-shaped device implanted in the medial compartment of Scroll down and select the appropriate advisory committee meeting link. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. Active Implants is privately held with headquarters in Memphis, Tennessee. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. 2022 Active Implants. Study design: Cohort study; Level of evidence, 2. 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. " [It] is designed for patients with persistent knee pain following medial meniscus surgery. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. CAUTION An official website of the United States government, : It is made from medical-grade polymer and, as a result of its unique materials, composite structure, and design, does not require fixation to bone or soft tissues. A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. Right now, Arbel says the only treatment for people who have a painful or degraded meniscus has been pain medications, physiotherapy, and intra-articular injections (directly into the joint) to relieve pain. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.[i]. Active Implants which specializes in orthopedic solutions and has operations in Memphis, Tennessee, the Netherlands, and Israel has begun marketing their product in the Middle East. 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. All rights reserved. Patient Population: . 2022 Active Implants. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. Investors are cautioned that actual events or results may differ from Active Implants expectations. The next day he started physiotherapy to gain full range of movement.. Factors that may affect the actual results achieved by Active Implants include, without limitation, the ability of Active Implants to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of Active Implants to integrate purchased businesses, R&D capabilities, infrastructure and employees. Press Releases | Active Implants | Orthopedic Implant Solutions r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov The device is currently marketed in Belgium, Germany, Italy, and Israel. Active Implants Appoints Ted Davis President and Chief Executive Officer. Medical Design & Manufacturing (MD&M) East 2023, New M&A Rejuvenates Robotics Sector in Medtech, Nanox.AI Expands Reach Through New Partnership, ZimVie's Mobi-C Wins Reimbursement in France.
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