nusurface meniscus implant fda approval

The NUsurfacemeniscus implant is the first artificial meniscus to be marketed in Europe and, if cleared by FDA, would be the first artificial meniscus in the United States, according to Active Implants. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. 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. 02/22/17. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 3 Things You Should Know Before Having Knee - Active Implants We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. The product is approved in Europe under CE regulations and in Israel. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. 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.. 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). J+XWcE2+mNG^Ni44y!RC!J4l] YAR "*QG!(a/+:D[tI`0\0414*4(aRabEmM9(C0geD/;83fgS7g9]cA9c 1>hxM5Hd 1#2^kx)h4@VTgFUjmRl=FFYCpTcK.j1.40VV b!40oq06CqU,:M[,fD& $y%.Hj1)#/1L7qIj-l0 0xLJ&R .`eE 3 r;#5515=0`d" 2s,-P udt@MgQ"H%+BRvS r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov If approved, it will be the first artificial meniscus in the United States. The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. 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. 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. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. Advanced Orthopedics & Sports Medicine Specialists Performs First. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. Copyright 2023 The Ohio State University Wexner Medical Center. Get tips from Ohio State experts right to your inbox. AGENCY: Food and Drug Administration, HHS. 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. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. 787 0 obj <>stream The artificial meniscus is made from medical-grade polymer and other unique materials. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. Previous Post First NUsurface Meniscus Implant - Active Implants Active Implants wins breakthrough nod for NUsurface knee implant The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. 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. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. However, it could still be years before this procedure is available in the United States. Number 8860726. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Written submissions may be made to the contact person on or before April 4, 2023. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. 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 U.S. Food and Drug Administration has granted "breakthrough. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. 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. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Can Manufacturing Technology Enhance Healthcare? 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 Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 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. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. I look forward to the opportunity to offer this exciting new technology to my patients when it is available in the U.S., stated Elliott Hershman, M.D., Chief Medical Advisor to Active Implants. Limited by United States law to investigational use. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. For more information, visit www.activeimplants.com. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The new procedure is a lot simpler than other options. 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. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. Please note: The lists in this section do not include every new medical device that has been cleared or approved for sale in the US. The device is a polymeric disc-shaped device implanted in the medial compartment of the knee to distribute load between the distal femur and proximal tibia and is intended to improve pain and function in the medial compartment of a knee in which the medial meniscus has been resected. h243Q0Pw/+Q0L)64 )Ic0i 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. 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. All rights reserved. Active Implants Appoints Ted Davis President and Chief Executive Officer. 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 NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. 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. The medial meniscus replacement mimics the .

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