nusurface meniscus implant fda approval

Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. 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. 1. 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. At Last an Artificial Meniscus - John Patrick The agency has been rapidly accepting devices into this pathway this year. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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.. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A NUsurface implant doesnt burn any bridges, Arbel said. 2022 Active Implants. The artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. 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 medial meniscus replacement is said to mimic the function of the natural meniscus and treat pain by redistributing loads transmitted across the knee joint. Current state of off the shelf scaffolds and implants for meniscal If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The NUsurface, which is the first artificial meniscus to be marketed in Europe, is currently being reviewed by the US Food and Drug Administration (FDA). First NUsurface Meniscus Implanted for Knee Osteoarthritis Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. 3 ). According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. 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 Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. 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. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. 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. The Venus trial is the culmination of years of development and testing of the NUsurface and follows a prospective, multi-center trial that enrolled 128 patients in centers in Europe and Israel. Dr. Hershman is Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York and team doctor of the New York Jets. A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. The .gov means its official.Federal government websites often end in .gov or .mil. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. 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. 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. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. To evaluate the preliminary results from 2 ongoing trials that are evaluating the safety and effectiveness of a synthetic polymer meniscal implant (NUsurface; Active Implants, LLC). The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. Active Implants Appoints Ted Davis President and Chief Executive Officer. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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. Investors are cautioned that actual events or results may differ from Active Implants expectations. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. For more information, visit www.activeimplants.com. Time allotted for each presentation may be limited. 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. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Can Manufacturing Technology Enhance Healthcare? Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. The NUsurface Implant was invented and developed in our R&D center in Israel. h24U0P6A [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ 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. Most people can begin to walk normally in about 3 months, he added. Active Implants Enters Partnership with Geistlich Pharma AG for The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. 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. 2022 Active Implants. Informa Markets, a trading division of Informa PLC. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. The product is approved in Europe under CE regulations and in Israel. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. 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. Active Implants wins breakthrough nod for NUsurface knee implant Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. The next day he started physiotherapy to gain full range of movement.. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Meniscal substitution, a developing and long-awaited demand 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. FDA Grants Breakthrough Designation to 'Artificial Meniscus The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. The contact person will notify interested persons regarding their request to speak by March 28, 2023. Two clinical trials are scheduled in the United States right now. 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 site is secure. Exclusion Criteria: These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. x{_w X& G 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. Arbel is encouraged by the results of studies of the new artificial meniscus. The artificial medial meniscus implant NUsurface meniscus implant (Active Implants, USA) is a non-anchored femur conforming implant, which is designed to sit within the medial compartment, between . The artificial meniscus is made from medical-grade polymer and other unique materials. New Medical Device May Eliminate Need for Some Knee Replacement Surgery, Meet Mako, the Robot Helping Doctors Perform Error-Free Surgeries, Knee Surgery That Reduces Pain But Doesnt Heal the Injury, Steroid Injections in the Knee and Hip Can Cause More Damage Than Previously Realized, Comparing Your Options for Carpometacarpal Arthroplasty, What to Expect from Ankle Replacement Surgery, Types of Surgery to Repair Joints: Arthroplasty and More, Your Guide to Hip Resurfacing Arthroplasty, Your Guide to Total and Partial Elbow Arthroplasty. @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a After the surgery, my patient started to walk with the aid of crutches, Arbel said. AGENCY: Food and Drug Administration, HHS. "In particular, it [is] seeking FDA approval of its NUsurface meniscus implant which is the first 'artificial meniscus'and intended to fill the gap between minimally invasive meniscus repair and total knee replacement.". The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov 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). 11.1 Panel Non -Voting Questions . The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. The products listed here include some of the newest medical technology available. 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]. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. 2023 Healthline Media LLC. sU, FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. After this procedure, patients no longer need prolonged protected weight bearing or braces. 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. CAUTION 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. First FDA Approved Artificial Meniscus - Medical Automation Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. 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. FDA NON-Voting Questions . Final approval by the FDA is expected this year. 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. " [It] is designed for patients with persistent knee pain following medial 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. Clinical studies outside the U.S. have demonstrated the potential clinical benefits of our NUsurface Meniscus Implant for patients with early knee osteoarthritis, said Henry Klyce, Chairman and CEO of Active Implants. 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. [It] is designed for patients with persistent knee pain following medial meniscus surgery. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Progressively, the implant will form a customized fit to the patients knee contour. But, we need a longer follow-up to verify it.. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. 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.. There is no need for any fixation with sutures, screws, glue, or other stuff. The meeting will be open to the public. As I wrote in . Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement 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. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. All statements regarding Active Implants expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as expects, reaffirms, intends, anticipates, plans, believes, seeks, estimates, optimistic, or variations of such words and similar expressions, are forward-looking statements. %PDF-1.6 % 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. Learn about when you might need ankle replacement surgery, how the procedure is done, and what you can expect from this surgery. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. 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. FDA Grants Breakthrough Device Designation for NUsurface Implant The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. 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 device is a polymeric disc-shaped device implanted in the medial compartment of 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. There haven't been many options for these patients, unfortunately. J Bone Joint Surg Am. MEMPHIS, Tenn. September 19, 2019 Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. Meniscus Clinical Trial I Ohio State Sports Medicine Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. 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. His pain started following that partial meniscectomy. Seven clinical sites in the United States are currently enrolling patients in the study, which is called the VENUS-trial (Verification of the Effectiveness of the NUsurface System). 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. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. Active Implants LLC, a privately held, multi-national company, is headquartered in Memphis, Tennessee USA, with additional offices in Driebergen, The Netherlands, and Netanya, Israel. 2022 Active Implants. hD We look forward to working closely with the FDA to expedite the review process for the NUsurface Implant 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., This will be significant for this patient population, who often dont have good treatment options, said Elliott Hershman, MD, practicing orthopedic surgeon and medical director for the NUsurface clinical trials. Study design: Cohort study; Level of evidence, 2. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. 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. Agar said in a press release that many people who get meniscal repairs later experience pain. The site is secure. TEAMS (captions):teams.microsoft.com/meetup. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. 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). Last Meniscus Implant Treated in Clinical Trial - Active Implants Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. MD+DI Online is part of the Informa Markets Division of Informa PLC. First polymer-based meniscus implant granted expedited review by FDA Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. . hU[O@+!d&DE5. 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. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. 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. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. 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. 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. endstream endobj 789 0 obj <>stream 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 meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. Please log on 20 minutes before the webcast to test your signal. Healthline Media does not provide medical advice, diagnosis, or treatment. 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. Surgery is usually only necessary for severe.

Missed Newspaper Delivery, Whydah Shipwreck Coins For Sale, Rhonda Vincent Daughter Wedding, Will Ct State Employees Get A Raise In 2022, Articles N