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. 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. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. app. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. Active Implants wins breakthrough nod for NUsurface knee implant 2023 Healthline Media LLC. Contact us today for more information about the NUsurface Meniscus Implant. 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. @yot-S7]X4w7&pD2)>`*lQ4DBit-0
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Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. It is made from medical-grade polymer, and, owing to its materials, composite structure, and design, does not require fixation to bone or soft tissues, according to the company. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. 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 . endstream
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The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. 3 Things You Should Know Before Having Knee - Active Implants The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 03/16/17. The NUsurface Implant was invented and developed in our R&D center in Israel. After the surgery, my patient started to walk with the aid of crutches, Arbel said. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed . FDA is committed to the orderly conduct of its advisory committee meetings. Our website services, content, and products are for informational purposes only. 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. Agar said in a press release that many people who get meniscal repairs later experience pain. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. 2022 Active Implants. MEMPHIS, Tenn. September 19, 2019 Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. After this procedure, patients no longer need prolonged protected weight bearing or braces. 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. Copyright 2023 The Ohio State University Wexner Medical Center. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? Can Manufacturing Technology Enhance Healthcare? We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. They act as shock absorbers and stabilize the knee. The agency has been rapidly accepting devices into this pathway this year. Limited by United States law to investigational use. The NUsurface is the first artificial meniscus to be marketed in Europe and is currently under review by the U.S. Food and Drug Administration (FDA). 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]. Healthline Media does not provide medical advice, diagnosis, or treatment. 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. Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. The Company believes the NUsurface device could be used to treat several hundreds of thousands of patients a year whose earlier meniscectomy treatments have not been successful but are not yet candidates for knee arthroplasty. Answers to commonly asked questions, including information regarding special accommodations due to a disability, may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. Medical Design & Manufacturing (MD&M) East 2023, New M&A Rejuvenates Robotics Sector in Medtech, Nanox.AI Expands Reach Through New Partnership, ZimVie's Mobi-C Wins Reimbursement in France. 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. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. All rights reserved. J+XWcE2+mNG^Ni44y!RC!J4l]
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udt@MgQ"H%+BRvS New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 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: . Active Implants Enters Partnership with Geistlich Pharma AG for 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. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. MEMPHIS, Tenn.(BUSINESS WIRE)Active Implants LLC today announced the first implantation in the United States of the NUsurface Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or deteriorated meniscus. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. 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.. Scroll down and select the appropriate advisory committee meeting link. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. You may have to refresh your browser before logging on. 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. ADDRESSES: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Web page addresses and e-mail addresses turn into links automatically. Peter Verdonk, M.D., PhD, an investigator in the Multi-Center trial from Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, said, I am impressed with the results observed to date and believe this technology could represent a new method of treating patients with meniscus problems who are often on a long and painful progression to knee replacement.. . The Venus trial is the culmination of years of development and testing of the NUsurface and follows a prospective, multi-center trial that enrolled 128 patients in centers in Europe and Israel. Dr. Hershman is Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York and team doctor of the New York Jets. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. 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. The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. J Bone Joint Surg Am. 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. The device is made from medical grade plastic and, as a result of its unique materials, composite structure, and design, does not require fixation to bone or soft tissues. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. endstream
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The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 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. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Investors are cautioned that actual events or results may differ from Active Implants expectations. Ted Davis, president and CEO of Memphis, TN-basedActive Implants, said the company expects to have the data required for an FDA submission next year. 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. h[n7OYEI 0Mf 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. "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 NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, American Academy of Orthopedic Surgeons Annua, Society for Arthroscopy and Joint Surgery / G, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. The product is approved in Europe under CE regulations and in Israel. 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). Seven clinical sites in the United States are currently enrolling patients in the study, which is called the VENUS-trial (Verification of the Effectiveness of the NUsurface System). New or current treatment with the NUsurface meniscus implant Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry. FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant Investigational device. MD+DI Online is part of the Informa Markets Division of Informa PLC. 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. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Once the meniscus is damaged, pain often sets in and can lead to arthritis and the need for knee replacement surgery, saysChristopher Kaeding, MD, (pictured left) the executive director of Ohio State Sports Medicine and the surgeon who implanted the device.This meniscal implant fills a gap in our treatment for those with meniscus injuries.. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm '
Copyright 2023. 2). 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. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov The NUsurface is a meniscus replacement prosthesis for treating knee pain in patients who have a damaged or dysfunctional meniscus from injury or after previous surgeries have failed. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. 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.