Investors are cautioned that actual events or results may differ from Active Implants expectations. FDA Breakthrough Device Designation Given To Active Implants For If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 03/16/17. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : Get tips from Ohio State experts right to your inbox. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. 1. Informa Markets, a trading division of Informa PLC. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. 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. Healthline Media does not provide medical advice, diagnosis, or treatment. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 2022 Active Implants. [It] is designed for patients with persistent knee pain following medial meniscus surgery. September 20, 2019 By Sean Whooley. 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.. 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. 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. If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. 2). 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 . FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY
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$shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. An estimated 750,000 such procedures are performed each year. r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The products listed here include some of the newest medical technology available. FDA Grants Breakthrough Device Designation for NUsurface Implant 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. 02/22/17. x{_w X& G This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. Active Implants wins breakthrough nod for NUsurface knee implant The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. 2022 Active Implants. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . @yot-S7]X4w7&pD2)>`*lQ4DBit-0
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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. Quest to Reach Another Segment in Liquid Biopsy with New M&A, MedCon 2023 Session Highlights MDUFA V, TAP Pilot, EU MDR, The Expanding Value of Medical Devices in a Digital World, Allowed HTML tags: . Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. Final approval by the FDA is expected this year. Active Implants partners with Geistlich Pharma for NUsurface 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. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. 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). First NUsurface Meniscus Implanted for Knee Osteoarthritis 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. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 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. 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. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The contact person will notify interested persons regarding their request to speak by March 28, 2023. h243Q0Pw/+Q0L)64 )Ic0i The artificial meniscus is made from medical-grade polymer and other unique materials. The NUsurface Implant was invented and developed in our R&D center in Israel. 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. h[n7OYEI 0Mf The .gov means its official.Federal government websites often end in .gov or .mil. The device is a polymeric disc-shaped device implanted in the medial compartment of Arbel is optimistic about the effectiveness of the new implant. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. After this procedure, patients no longer need prolonged protected weight bearing or braces. 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 new procedure is a lot simpler than other options. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. 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. People who have the surgery typically can go home soon after the operation. Time allotted for each presentation may be limited. 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). The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. 2023 Healthline Media LLC. The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, Davis said. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. 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Meniscal substitution, a developing and long-awaited demand But, we need a longer follow-up to verify it.. 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 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. Copyright 2023 The Ohio State University Wexner Medical Center. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. 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. 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 implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. 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. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. 05/01/17. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Continued pain after repairing meniscus tears is a very common orthopedic problem, and until now, we have not had effective treatment options., Ted Davis, president and CEO of Active Implants, said, Filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement is a large unmet need in the orthopedic market. Meniscus Clinical Trial I Ohio State Sports Medicine 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. Active Implants Enters Partnership with Geistlich Pharma AG for The other is expected to be completed in 2023. Advanced Orthopedics & Sports Medicine Specialists Performs First. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. 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.. 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. Please log on 20 minutes before the webcast to test your signal. sU,
'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief 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. First FDA Approved Artificial Meniscus - Medical Automation Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. 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. At Last an Artificial Meniscus - John Patrick CAUTION Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. The site is secure. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 27, 2023. Investors are cautioned that actual events or results may differ from Active Implants expectations. The first is expected to be completed sometime next year. 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 . The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. 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. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. 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. 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]. You may have to refresh your browser before logging on. Previous Post First NUsurface Meniscus Implant - Active Implants Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. FDA is committed to the orderly conduct of its advisory committee meetings. 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. +'%F[jjY#g= k$a9i \
4 hpk.JItq8N " TEAMS (captions):teams.microsoft.com/meetup. Before sharing sensitive information, make sure you're on a federal government site. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. NUsurface Meniscus Implant for Persistent Knee Pain - 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. 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 device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. endstream
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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 Limited by United States law to investigational use. The meeting will be open to the public. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant The product is approved in Europe under CE regulations and in Israel. Investigational device. 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. Biomaterials for meniscus and cartilage in knee surgery: state of the 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. 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. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. Registered in England and Wales. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the
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