nusurface meniscus implant fda approval

Meniscal substitution, a developing and long-awaited demand Meniscus Replacements in Colorado with NUsurface Meniscus Implant. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. AGENCY: Food and Drug Administration, HHS. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 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. Advanced Orthopedics & Sports Medicine Specialists Performs First. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. Healthline Media does not provide medical advice, diagnosis, or treatment. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. %PDF-1.6 % 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. The device is a polymeric disc-shaped device implanted in the medial compartment of If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial NUsurface - Rimoni Industries 3 Things You Should Know Before Having Knee - Active Implants Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Press Releases | Active Implants | Orthopedic Implant Solutions Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : Current state of off the shelf scaffolds and implants for meniscal 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.The "VENUS"-study (Verification of the Effectiveness of the . 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. FDA NON-Voting Questions . If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDAs website at the time of the advisory committee meeting, and the background material will be posted on FDAs website after the meeting. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Active Implants is privately held with headquarters in Memphis, Tennessee. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. "If this meniscal implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries." Kaeding said. The next day he started physiotherapy to gain full range of movement.. [It] is designed for patients with persistent knee pain following medial meniscus surgery. The artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. 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. 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:

. His pain started following that partial meniscectomy. Meniscus Clinical Trial I Ohio State Sports Medicine You can find additional information at the links below: PMA Approvals: Monthly listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway.These . The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. The other is expected to be completed in 2023. 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. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. 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. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. 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. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The Company believes the NUsurface device could treat hundreds of thousands of patients per year whose previous partial meniscectomy surgery was not successful and yet are not ready or old enough for knee arthroplasty. You may have to refresh your browser before logging on. Please log on 20 minutes before the webcast to test your signal. Investors are cautioned that actual events or results may differ from Active Implants expectations. Copyright 2023 The Ohio State University Wexner Medical Center. Patient Population: . The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. Can Manufacturing Technology Enhance Healthcare? Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. For the first time in the U.S., surgeons at The Ohio State University Wexner Medical Center have implanted a plastic device designed to help patients with persistent knee pain due to injured or deteriorating meniscus cartilage. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Our website services, content, and products are for informational purposes only. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. 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. hD If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. Arbel is encouraged by the results of studies of the new artificial meniscus. They act as shock absorbers and stabilize the knee. Final approval by the FDA is expected this year. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants 787 0 obj <>stream [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. The NUsurface Meniscus Implant was designed to meet the needs of patients too old for meniscus repair and too young for a knee replacement., For the past three years, Active Implants has been working with leading knee sports medicine surgeons in Belgium, Italy, Israel, The Netherlands, Sweden and Germany to conduct a prospective controlled, Multi-Center Trial of the NUsurface Meniscus Implant. No need to drill into or cut the bone. The VENUS-study (Verification of the Effectiveness of the NUsurface System) is a prospective, randomized, multicenter study to demonstrate superiority of the NUsurface Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. Before sharing sensitive information, make sure you're on a federal government site. 05/01/17. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. 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. FDA NON-Voting Questions The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. The procedure was performed as part of a pivotal trial to demonstrate the superiority of the NUsurface Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. Advisory Committee Calendar, Recalls, Market Withdrawals and Safety Alerts, April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 04/20/2023, https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings, https://www.fda.gov/AdvisoryCommittees/default.htm, https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm, https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm, Common Questions and Answers about FDA Advisory Committee Meetings, Public Conduct During FDA Advisory Committee Meetings, ORDP April 20, 2023 FDA Executive Summary, ORDP April 20, 2023 FDA Non-Voting Questions, ORDP April 20, 2023 NUsurface Executive Summary. First NUsurface Meniscus Implanted for Knee Osteoarthritis The .gov means its official.Federal government websites often end in .gov or .mil. If you require accommodations due to a disability, please contact Artair.Mallett@fda.hhs.gov or 301-796-9638 at least 7 days in advance of the meeting. Following these measures, the person has had to wait until the cartilage has deteriorated severely to the point where the knee needs to be replaced with an artificial implant made of metal and plastic. The product is approved in Europe under CE regulations and in Israel. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. Two clinical trials are scheduled in the United States right now. All rights reserved. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. The device is currently marketed in Belgium, Germany, Italy, and Israel. MORE, Light-Activated Molecular Machines for Antifungal Therapy, 3D Printing the Outer Blood-Retina Barrier. sU, These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. 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 device is approved in Europe under CE regulations and in Israel. endstream endobj 789 0 obj <>stream The new procedure is a lot simpler than other options. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. Learn about when you might need ankle replacement surgery, how the procedure is done, and what you can expect from this surgery.

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