nusurface meniscus implant fda approval

This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. 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. [+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. 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. 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. So, for us, it is very exciting to finally bring the device to people in Israel.. These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 2022 Active Implants. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Previous Post First NUsurface Meniscus Implant - Active Implants As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. If you require accommodations due to a disability, please contact Artair.Mallett@fda.hhs.gov or 301-796-9638 at least 7 days in advance of the meeting. 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 . 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. 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. 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). FDA NON-Voting Questions MD+DI Online is part of the Informa Markets Division of Informa PLC. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. 787 0 obj <>stream Active Implants Enters Partnership with Geistlich Pharma AG for Arbel is encouraged by the results of studies of the new artificial meniscus. Informa Markets, a trading division of Informa PLC. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. This new program is designed to expedite the development and review process for medical devices that are innovative or offer new technology for people whose conditions are life threatening or irreversibly debilitating. 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. First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation, Medtech in a Minute: A Shocking M&A Rumor, and More, Medtech in a Minute: Medtronic Layoffs, and More. 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. . 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. So, we think that it will prevent or delay the need for total knee replacement, he said. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. app. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! There is no need for any fixation with sutures, screws, glue, or other stuff. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. 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 "VENUS"-study (Verification of the Effectiveness of the . endstream endobj 788 0 obj <>stream We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. No need to drill into or cut the bone. The agency has been rapidly accepting devices into this pathway this year. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. The NUsurface Implant was invented and developed in our R&D center in Israel. The device is currently marketed in Belgium, Germany, Italy, and Israel. MORE, Light-Activated Molecular Machines for Antifungal Therapy, 3D Printing the Outer Blood-Retina Barrier. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. 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. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. FDA Grants Breakthrough Device Designation for NUsurface Implant The device is currently marketed in Belgium, Germany, Italy, and Israel. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. The SUN and VENUS U.S. clinical trials completed enrollment in June 2018, and Active Implants is expecting to file for regulatory approval in the U.S. in the next two years. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. 2023 Healthline Media LLC. 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). 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 artificial meniscus is made from medical-grade polymer and other unique materials. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. After this procedure, patients no longer need prolonged protected weight bearing or braces. Scroll down and select the appropriate advisory committee meeting link. Investigational device. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The site is secure. The product is approved in Europe under CE regulations and in Israel. The Breakthrough Device Designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, said Ted Davis, president and CEO of Active Implants. 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. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. 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. Factors that may affect the actual results achieved by Active Implants include, without limitation, the ability of Active Implants to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of Active Implants to integrate purchased businesses, R&D capabilities, infrastructure and employees. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 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 implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. "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. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. Press Releases | Active Implants | Orthopedic Implant Solutions 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. Please log on 20 minutes before the webcast to test your signal. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. 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. Written submissions may be made to the contact person on or before April 4, 2023. An official website of the United States government, : 2). Active Implants partners with Geistlich Pharma for NUsurface 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. All rights reserved. Investors are cautioned that actual events or results may differ from Active Implants expectations. A NUsurface implant doesnt burn any bridges, Arbel said.

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