Scroll down and select the appropriate advisory committee meeting link. First FDA Approved Artificial Meniscus - Medical Automation FDA Grants Breakthrough Device Designation for NUsurface Implant NUsurface - Rimoni Industries Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. So, for us, it is very exciting to finally bring the device to people in Israel.. People who have the surgery typically can go home soon after the operation. Preliminary Results From a US Clinical Trial of a Novel - PubMed The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. Progressively, the implant will form a customized fit to the patients knee contour. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 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. The implant is made from a medical-grade plastic. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. 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.. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. 3 Things You Should Know Before Having Knee - Active Implants 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). Active Implants Appoints Ted Davis President and Chief Executive Officer. J Bone Joint Surg Am. 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. 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. An official website of the United States government, : The device is a polymeric disc-shaped device implanted in the medial compartment of The NUsurface Meniscus Implant was designed to meet the needs of patients too old for meniscus repair and too young for a knee replacement., For the past three years, Active Implants has been working with leading knee sports medicine surgeons in Belgium, Italy, Israel, The Netherlands, Sweden and Germany to conduct a prospective controlled, Multi-Center Trial of the NUsurface Meniscus Implant. There arent many options for these patients, unfortunately. 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 meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. 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. Before sharing sensitive information, make sure you're on a federal government site. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The device is currently marketed in Belgium, Germany, Italy, and Israel. 2). Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. Learn about when you might need ankle replacement surgery, how the procedure is done, and what you can expect from this surgery. The FDA 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 NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. 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 implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 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. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. Recently-Approved Devices | FDA 11.1 Panel Non -Voting Questions . If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. 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 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. Copyright 2023. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a 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. 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. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. Number 8860726. After this procedure, patients no longer need prolonged protected weight bearing or braces. "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. endstream endobj 792 0 obj <>stream 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. The .gov means its official.Federal government websites often end in .gov or .mil. "cC*RS The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. 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. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. Web page addresses and e-mail addresses turn into links automatically. 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. ^>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? Meniscal substitution, a developing and long-awaited demand The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. 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. At Last an Artificial Meniscus - John Patrick The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. endstream endobj 791 0 obj <>stream Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant Lines and paragraphs break automatically. Patient Population: . 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. 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. For more information, visit www.activeimplants.com. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 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 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. All rights reserved. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. 02/22/17. 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. In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for . Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant 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. 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. Previous Post First NUsurface Meniscus Implant - Active Implants 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. A NUsurface implant doesnt burn any bridges, Arbel said. Active Implants is privately held with headquarters in Memphis, Tennessee. 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. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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 . Download : Download high-res image (115KB) 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. Investors are cautioned that actual events or results may differ from Active Implants expectations. 03/16/17. 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. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. h[n7OYEI 0Mf Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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.
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