About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to help relieve knee pain and restore function similar to that of the healthy meniscus. FDA Grants Breakthrough Designation to 'Artificial Meniscus This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. 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: info@activeimplants.com or visit: www.activeimplants.com. The meeting will be open to the public. The agency has been rapidly accepting devices into this pathway this year. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Ill also advise patients to have the implant immediately after a partial medial meniscectomy to prevent degeneration of their cartilage., After more than 10 years in clinical trials, it is an exciting time to finally be able to make the NUsurface Implant available to Israeli patients, he said, according to prepared remarks. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. There haven't been many options for these patients, unfortunately. After the surgery, my patient started to walk with the aid of crutches, Arbel said. 05/01/17. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. 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 . 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Subscribe. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 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. 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.. 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. The implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. 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 trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Scroll down and select the appropriate advisory committee meeting link. Active Implants is privately held with headquarters in Memphis, Tennessee. Biomaterials for meniscus and cartilage in knee surgery: state of the Web page addresses and e-mail addresses turn into links automatically. 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. Therefore, you should always check the agencys website or call the committees Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. See additional information. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. Number 8860726. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. Knee Pain Treatment in the Netherlands - Active Implants Active Implants Appoints Ted Davis President and Chief Executive Officer. J Bone Joint Surg Am. The device is currently marketed in Belgium, Germany, Italy, and Israel. Active Implants LLC, a privately held, multi-national company, is headquartered in Memphis, Tennessee USA, with additional offices in Driebergen, The Netherlands, and Netanya, Israel. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. So, for us, it is very exciting to finally bring the device to people in Israel.. The artificial meniscus is made from medical-grade polymer and other unique materials. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. app. About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to relieve knee pain and restore function similar to that of the natural healthy meniscus. 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). 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. 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. FDA NON-Voting Questions Investigational device. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in 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. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. endstream endobj 790 0 obj <>stream Investors are cautioned that actual events or results may differ from Active Implants expectations. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. 787 0 obj <>stream Copyright 2023 The Ohio State University Wexner Medical Center. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. MD+DI Online is part of the Informa Markets Division of Informa PLC. 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. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. endstream endobj 792 0 obj <>stream Preliminary Results From a US Clinical Trial of a Novel - PubMed The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. Clinical studies outside the USA have shown that the NUsurface Meniscus Implant results in significant pain relief and restoration of function compared to currently available treatments, said Henry Klyce, Chairman and CEO of Active Implants. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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. 1. 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. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. The medial meniscus replacement mimics the .