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. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. 1. Two clinical trials are scheduled in the United States right now. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. Written submissions may be made to the contact person on or before April 4, 2023. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. 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. First FDA Approved Artificial Meniscus - Medical Automation Patient Population: . Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. If approved, it will be the first artificial meniscus in the United States. 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). These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. At Last an Artificial Meniscus - John Patrick 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. 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. Lines and paragraphs break automatically. 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.. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 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. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. The products listed here include some of the newest medical technology available. You may have to refresh your browser before logging on. Subscribe. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. "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. 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. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. %PDF-1.6 % 02/22/17. The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. 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. 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. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. sU, 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. 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. 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.. They act as shock absorbers and stabilize the knee. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. 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. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. U.S. patients who continue to suffer fromknee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. MD+DI Online is part of the Informa Markets Division of Informa PLC. 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. There arent many options for these patients, unfortunately. Meniscal substitution, a developing and long-awaited demand FDA is committed to the orderly conduct of its advisory committee meetings. Arbel is optimistic about the effectiveness of the new implant. Copyright 2023. 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. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. Advanced Orthopedics & Sports Medicine Specialists Performs First. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. 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. Number 8860726. Johns Hopkins Medicine researchers found that a common surgery known as arthroscopic partial meniscectomy accounted for an estimated two-thirds of all orthopedic knee arthroscopy procedures in older patients in 2016 and that this surgery may not even be that effective. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 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 Ohio State University Wexner Medical Center, https://clinicaltrials.gov/show/NCT02108496. Im pleased to hear the FDA will prioritize its review of this important new device and possibly make this therapy available for use by other knee surgeons for their American patients., The meniscus is a tissue pad between the thigh and shin bones. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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 medial meniscus replacement is said to mimic the function of the natural meniscus and treat pain by redistributing loads transmitted across the knee joint. Active Implants LLC is a privately held, multi-national company headquartered in Memphis, Tennessee USA with additional offices in Driebergen, The Netherlands, and Netanya, Israel. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. Most people can begin to walk normally in about 3 months, he added. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. FDA is committed to the orderly conduct of its advisory committee meetings. Previous Post First NUsurface Meniscus Implant - Active Implants The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. There is no need for any fixation with sutures, screws, glue, or other stuff. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants The agency has been rapidly accepting devices into this pathway this year. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. An estimated 750,000 such procedures are performed each year. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. Current state of off the shelf scaffolds and implants for meniscal Please log on 20 minutes before the webcast to test your signal. So, for us, it is very exciting to finally bring the device to people in Israel.. 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. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. For more information, visit www.activeimplants.com. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. h243Q0Pw/+Q0L)64 )Ic0i Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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 surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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 . "cC*RS 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. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. Evaluation of performance defined as NUsurface Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 60 months post-implantation, as measured by KOOS Pain and KOOS 5 Eligibility Criteria Go to Information from the National Library of Medicine The medial meniscus replacement mimics the . Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. However, it could still be years before this procedure is available in the United States. FDA NON-Voting Questions . Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. 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 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. 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. Dr. Hershman said, The NUsurface Meniscus Implant is a novel, composite polymer implant, which is used to treat knee patients who have pain and disability arising from osteoarthritis caused by a previous meniscectomy, meniscus dysfunction or insufficiency. The product is approved in Europe under CE regulations and in Israel. 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. The NUsurface Implant was invented and developed in our R&D center in Israel. 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. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. As I wrote in . h24U0P6A They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable.

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