The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. The NUsurface is designed to replace the damaged or deteriorating medial (inner) meniscus in your knee while leaving the rest of your knee joint intact. They act as shock absorbers and stabilize the knee. The artificial meniscus is made from medical-grade polymer and other unique materials. Continued pain after repairing meniscus tears is a very common orthopedic problem, and until now, we have not had effective treatment options., Ted Davis, president and CEO of Active Implants, said, Filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement is a large unmet need in the orthopedic market. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Press Releases | Active Implants | Orthopedic Implant Solutions Active Implants Enters Partnership with Geistlich Pharma AG for Healthline Media does not provide medical advice, diagnosis, or treatment. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. FDA NON-Voting Questions You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. 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). 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. 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. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. 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 artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. Before sharing sensitive information, make sure you're on a federal government site. 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. It also prevents further degeneration of the cartilage that happens when part of the meniscus is removed after a tear, or in case of a nonfunctioning, degraded meniscus.. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. 2022 Active Implants. So, we think that it will prevent or delay the need for total knee replacement, he said. The new procedure is a lot simpler than other options. The NUsurface Meniscus Implant is the first artificial meniscus to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the U.S. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. app. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or avoid a knee replacement surgery altogether, Kaeding says. 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.. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. An estimated 750,000 such procedures are performed each year. Recent breakthrough device designations include a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, aninteratrial shunt for heart failure from V-Wave, B. Braun'sdrug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronaryintravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze,and two cancer diagnostic tests. We look forward to working closely with the FDA to expedite the review process for the NUsurface Implant 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., This will be significant for this patient population, who often dont have good treatment options, said Elliott Hershman, MD, practicing orthopedic surgeon and medical director for the NUsurface clinical trials. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 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. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews AGENCY: Food and Drug Administration, HHS. An official website of the United States government, : 3 ). 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]. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial As I wrote in . A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. First FDA Approved Artificial Meniscus - Medical Automation Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. endstream endobj 792 0 obj <>stream 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. 05/01/17. The mission of Active Implants LLC is to develop orthopaedic implant solutions that integrate with the natural biomechanics of the musculoskeletal system and allow patients to maintain or return to an active lifestyle. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. endstream endobj 788 0 obj <>stream U.S. patients who continue to suffer fromknee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. 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. 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. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. The medial meniscus replacement is said to mimic the function of the natural meniscus and treat pain by redistributing loads transmitted across the knee joint. First polymer-based meniscus implant granted expedited review by FDA 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. But, we need a longer follow-up to verify it.. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Quest to Reach Another Segment in Liquid Biopsy with New M&A, MedCon 2023 Session Highlights MDUFA V, TAP Pilot, EU MDR, The Expanding Value of Medical Devices in a Digital World, Allowed HTML tags:

. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation, Medtech in a Minute: A Shocking M&A Rumor, and More, Medtech in a Minute: Medtronic Layoffs, and More. "Active Implants has commercialized two unique orthopedic implants in Europe with a visible pathway to bring them into the U.S.," Matson noted in his June 2019 report.
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