Before sharing sensitive information, make sure you're on a federal government site. Advanced Orthopedics & Sports Medicine Specialists Performs First. Active Implants wins breakthrough nod for NUsurface knee implant If approved, it will be the first artificial meniscus in the United States. Exclusion Criteria: @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. 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 . ^>T&.~Tp>4wN F8*U#o"AQb`rD9@*hD 39xa -lMF{';j{vrwTfD!h>(tZ}[!OFR]x69R]LWxJ(.v: W!-n:vpy!J[=>nQo,)*(~eCd:e6. a:;z3|/ ']i N2uy^ .rGX^ob3IJcA1U}A0X*p!\h"&UL,%_ebW@E#0~Q_("J_CjEG\C}c7`,zud? The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. After this procedure, patients no longer need prolonged protected weight bearing or braces. The NUsurface Implant was invented and developed in our R&D center in Israel. 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 Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. The agency has been rapidly accepting devices into this pathway this year. The implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews See additional information. . 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 artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. Scroll down and select the appropriate advisory committee meeting link. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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. 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. 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. sU, Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. (T)fu;$@%PXGZy,/y bB>d0{axN6?%:~%d4}^$}d}_D*-)?%edRx,@0ud@#xgYB{'B`J!F0CxJ0:*iCQ}.cb1qIG%: First polymer-based meniscus implant granted expedited review by FDA Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 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. There is no need for any fixation with sutures, screws, glue, or other stuff. 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. First NUsurface Meniscus Implanted for Knee Osteoarthritis The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. 3 Things You Should Know Before Having Knee - Active Implants 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. 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. 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. 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. After the surgery, my patient started to walk with the aid of crutches, Arbel said. So, for us, it is very exciting to finally bring the device to people in Israel.. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. 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. Recent breakthrough device designations include a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, aninteratrial shunt for heart failure from V-Wave, B. Braun'sdrug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronaryintravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze,and two cancer diagnostic tests. 2023 Healthline Media LLC. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. September 20, 2019 By Sean Whooley. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. 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.. 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. The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant Agar said in a press release that many people who get meniscal repairs later experience pain. An estimated 750,000 such procedures are performed each year. Download : Download high-res image (115KB) FDA Grants Breakthrough Device Designation for Artificial Meniscus FDA Grants Breakthrough Device Designation for NUsurface Implant FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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. Knee Pain Treatment in the Netherlands - Active Implants According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. 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.
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