First NUsurface Meniscus Implanted for Knee Osteoarthritis Before sharing sensitive information, make sure you're on a federal government site. The initial surgery took place during an FDA-approved trial ofthe NUsurface Meniscus comparing it to the current standard of care for patients with persistent knee pain following meniscus surgery. 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.. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. The site is secure. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Active Implants wins breakthrough nod for NUsurface knee implant Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings. If those trials prove to be successful, the device would still need to be approved by the FDA before it could be available in the United States. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. The NUsurface is a meniscus replacement prosthesis for treating knee pain in patients who have a damaged or dysfunctional meniscus from injury or after previous surgeries have failed. 5214, Silver Spring, MD 20993-0002, [email protected], 301-636-0512, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. The implant is made from a medical-grade plastic. Dr. Hershman said, The NUsurface Meniscus Implant is a novel, composite polymer implant, which is used to treat knee patients who have pain and disability arising from osteoarthritis caused by a previous meniscectomy, meniscus dysfunction or insufficiency. If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. Michael Keenan, Chief Financial Officer at 901 762-0352 or Lex R. Giltaij, M.D., M.B.A., President and Chief Operating Officer of Active Implants at +31 (343) 200 140, or email: [email protected] or visit: www.activeimplants.com. This new program is designed to expedite the development and review process for medical devices that are innovative or offer new technology for people whose conditions are life threatening or irreversibly debilitating.
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