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). 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. I look forward to the opportunity to offer this exciting new technology to my patients when it is available in the U.S., stated Elliott Hershman, M.D., Chief Medical Advisor to Active Implants. The NUsurface meniscus implant is designed to provide a new treatment option to the hundreds of thousands of patients who continue to experience persistent knee pain following meniscus surgery, but are too young for total knee replacement, said the company in a news release. A NUsurface implant doesnt burn any bridges, Arbel said. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. Progressively, the implant will form a customized fit to the patients knee contour. h24U0P6A As I wrote in . The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. NUsurface - Rimoni Industries '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov You may have to refresh your browser before logging on. Scroll down and select the appropriate advisory committee meeting link. The Venus trial is the culmination of years of development and testing of the NUsurface and follows a prospective, multi-center trial that enrolled 128 patients in centers in Europe and Israel. Dr. Hershman is Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York and team doctor of the New York Jets. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' This program is designed to ensure patients and healthcare providers have more timely access to vital devices. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. The device is approved in Europe under CE regulations and in Israel. So, for us, it is very exciting to finally bring the device to people in Israel.. FDA is committed to the orderly conduct of its advisory committee meetings. Evaluation of performance defined as NUsurface Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 60 months post-implantation, as measured by KOOS Pain and KOOS 5 Eligibility Criteria Go to Information from the National Library of Medicine +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed . The .gov means its official.Federal government websites often end in .gov or .mil. The artificial medial meniscus implant NUsurface meniscus implant (Active Implants, USA) is a non-anchored femur conforming implant, which is designed to sit within the medial compartment, between . 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. Meniscal substitution, a developing and long-awaited demand Can Manufacturing Technology Enhance Healthcare? The .gov means its official.Federal government websites often end in .gov or .mil. Although the clinical use of the NUsurface Meniscus Implant started in Europe and Israel in 2008 and 2011, respectively, evidence-based clinical data remains largely absent. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Arbels patient, a 54-year-old man, suffered from knee pain after a surgeon removed about one-third of his medial meniscus, which was torn during athletic activity. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. For each product, you can find information about what the device is, how it works, when it can be used, and when it should not be used. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The procedure was performed by Christopher Kaeding, M.D., Professor and Executive Director, of OSU Sports Medicine at The Ohio State University Wexner Medical Center in Columbus, OH. The NUsurface Implant was invented and developed in our R&D center in Israel. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. The next day he started physiotherapy to gain full range of movement.. The device is a polymeric disc-shaped device implanted in the medial compartment of the knee to distribute load between the distal femur and proximal tibia and is intended to improve pain and function in the medial compartment of a knee in which the medial meniscus has been resected. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. The site is secure. TEAMS (captions):teams.microsoft.com/meetup. An official website of the United States government, : MEMPHIS, Tenn.(BUSINESS WIRE)Active Implants LLC today announced the first implantation in the United States of the NUsurface Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or deteriorated meniscus. 5214, Silver Spring, MD 20993-0002, Akinola.Awojope@fda.hhs.gov, 301-636-0512, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). No need to drill into or cut the bone. The device is currently marketed in Belgium, Germany, Italy, and Israel. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Lines and paragraphs break automatically.