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. 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. 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. NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Current state of off the shelf scaffolds and implants for meniscal Active Implants Appoints Ted Davis President and Chief Executive Officer. Previous Post First NUsurface Meniscus Implant - Active Implants Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. 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. J Bone Joint Surg Am. 787 0 obj <>stream 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. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. An estimated 750,000 such procedures are performed each year. The contact person will notify interested persons regarding their request to speak by March 28, 2023. app.2). The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. The procedure was performed by Christopher Kaeding, M.D., Professor and Executive Director, of OSU Sports Medicine at The Ohio State University Wexner Medical Center in Columbus, OH. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY ZhIU#F|;@72s## @Fia( $shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. 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. 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. His pain started following that partial meniscectomy. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. 2). Limited by United States law to investigational use. You may have to refresh your browser before logging on. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The product is approved in Europe under CE regulations and in Israel. 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. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. Healthline Media does not provide medical advice, diagnosis, or treatment. x{_w X& G This program is designed to ensure patients and healthcare providers have more timely access to vital devices. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : endstream endobj 792 0 obj <>stream Progressively, the implant will form a customized fit to the patients knee contour. . FDA Grants Breakthrough Device Designation for Artificial Meniscus 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. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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. 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. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. The agency has been rapidly accepting devices into this pathway this year. 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 NUsurface is designed to replace the damaged or deteriorating medial (inner) meniscus in your knee while leaving the rest of your knee joint intact. On April 20, 2023, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. 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. endstream endobj 789 0 obj <>stream He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. Informa Markets, a trading division of Informa PLC. The FDA 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. Active Implants LLC, a developer of orthopedic implant solutions for joint preservation, said its NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. h[n7OYEI 0Mf "cC*RS CAUTION request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. There is no need for any fixation with sutures, screws, glue, or other stuff. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? There arent many options for these patients, unfortunately. @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. 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. But, we need a longer follow-up to verify it.. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 03/16/17. All statements regarding Active Implants expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as expects, reaffirms, intends, anticipates, plans, believes, seeks, estimates, optimistic, or variations of such words and similar expressions, are forward-looking statements.
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