First polymer-based meniscus implant granted expedited review by FDA The SUN and VENUS U.S. clinical trials completed enrollment in June 2018, and Active Implants is expecting to file for regulatory approval in the U.S. in the next two years. 2022 Active Implants. Get tips from Ohio State experts right to your inbox. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. FDA NON-Voting Questions People who have the surgery typically can go home soon after the operation. New Medical Device May Eliminate Need for Some Knee Replacement Surgery, Meet Mako, the Robot Helping Doctors Perform Error-Free Surgeries, Knee Surgery That Reduces Pain But Doesnt Heal the Injury, Steroid Injections in the Knee and Hip Can Cause More Damage Than Previously Realized, Comparing Your Options for Carpometacarpal Arthroplasty, What to Expect from Ankle Replacement Surgery, Types of Surgery to Repair Joints: Arthroplasty and More, Your Guide to Hip Resurfacing Arthroplasty, Your Guide to Total and Partial Elbow Arthroplasty. sU, Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. Knee Pain Treatment in the Netherlands - Active Implants Number 8860726. The initial surgery took place during an FDA-approved trial of the NUsurface Meniscus comparing it to the current standard of care for patients with persistent knee pain following meniscus surgery. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. MEMPHIS, Tenn.(BUSINESS WIRE)Active Implants, the technology leader in cushion-bearing orthopedics for treatment of osteoarthritis, today announced it has received Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial of the NUsurface Meniscus Implant in patients with knee osteoarthritis.
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