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 .gov means its official.Federal government websites often end in .gov or .mil. FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. FDA NON-Voting Questions 2). 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 procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. "Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement." The implant is made from a medical grade plastic called, polycarbonate-urethane. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. 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. 3 ). If you require accommodations due to a disability, please contact the committees Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting. 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). The agency has been rapidly accepting devices into this pathway this year. 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 . April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the All rights reserved. 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 polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. The contact person will notify interested persons regarding their request to speak by March 28, 2023. Therefore, you should always check the Agencys website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. 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. 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). Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. No need to drill into or cut the bone. The product is approved in Europe under CE regulations and in Israel. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. FDA Grants Breakthrough Device Designation for Artificial Meniscus However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. 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. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. 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. Earlier this year Active Implants gained some attention from Needham & Co.'s Mike Matson, who included the company on a list of interesting private medtech companies. 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. FDA intends to make background material available to the public no later than 2 business days before the meeting. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. All rights reserved. Can Manufacturing Technology Enhance Healthcare? FDA is committed to the orderly conduct of its advisory committee meetings. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The products listed here include some of the newest medical technology available. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Recently-Approved Devices | FDA The meeting will be open to the public. CAUTION 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 Implant Registry - Full Text View - ClinicalTrials.gov As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Written submissions may be made to the contact person on or before April 4, 2023. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. hU[O@+!d&DE5. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. There arent many options for these patients, unfortunately. Previous Post First NUsurface Meniscus Implant - Active Implants MD+DI Online is part of the Informa Markets Division of Informa PLC. 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. 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 NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. 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. The U.S. Food and Drug Administration has granted "breakthrough. Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. 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. "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. Learn about when you might need ankle replacement surgery, how the procedure is done, and what you can expect from this surgery. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. Investors are cautioned that actual events or results may differ from Active Implants expectations. AGENCY: Food and Drug Administration, HHS. 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.. 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]. Final approval by the FDA is expected this year. An official website of the United States government, : 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. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. FDA NON-Voting Questions . 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.