Can Manufacturing Technology Enhance Healthcare? What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. FDA NON-Voting Questions 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. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. 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. AGENCY: Food and Drug Administration, HHS. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov NUsurface - Rimoni Industries Active Implants Appoints Ted Davis President and Chief Executive Officer. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' 2022 Active Implants. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. endstream endobj 788 0 obj <>stream The .gov means its official.Federal government websites often end in .gov or .mil. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. "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. 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. Exclusion Criteria: Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. %PDF-1.6 % Get tips from Ohio State experts right to your inbox. Investors are cautioned that actual events or results may differ from Active Implants expectations. 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. Two clinical trials are scheduled in the United States right now. 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 . FDA Breakthrough Device Designation Given To Active Implants For As I wrote in . request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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). Active Implants is privately held with headquarters in Memphis, Tennessee. The other is expected to be completed in 2023. The next day he started physiotherapy to gain full range of movement.. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. The NUsurface is a meniscus replacement prosthesis for treating knee pain in patients who have a damaged or dysfunctional meniscus from injury or after previous surgeries have failed. So, we think that it will prevent or delay the need for total knee replacement, he said. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. For more information, visit www.activeimplants.com. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. You may have to refresh your browser before logging on. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 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. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Informa Markets, a trading division of Informa PLC. 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. FDA Grants Breakthrough Device Designation for Artificial Meniscus Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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. 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. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. Previous Post First NUsurface Meniscus Implant - Active Implants Arbel is optimistic about the effectiveness of the new implant. CAUTION The products listed here include some of the newest medical technology available. Active Implants wins breakthrough nod for NUsurface knee implant 2022 Active Implants. Knee Pain Treatment in the Netherlands - Active Implants 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 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. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. There arent many options for these patients, unfortunately. See additional information. The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. After the surgery, my patient started to walk with the aid of crutches, Arbel said. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. After this procedure, patients no longer need prolonged protected weight bearing or braces. 2023 Healthline Media LLC. 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. Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial 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). If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief If you require accommodations due to a disability, please contact [email protected] or 301-796-9638 at least 7 days in advance of the meeting. 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. 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. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Copyright 2023. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. 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 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. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 03/16/17. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. 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 polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. 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. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. Meniscal substitution, a developing and long-awaited demand First polymer-based meniscus implant granted expedited review by FDA The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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.. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. And, in case the implant doesnt fit the patient, which very rarely happens, it can be taken out and the knee is back to the same situation as before the implantation.. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. 02/22/17. Press Releases | Active Implants | Orthopedic Implant Solutions 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. 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. 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 The Ohio State University Wexner Medical Center. 787 0 obj <>stream 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. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. TEAMS (captions):teams.microsoft.com/meetup. 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. 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. No need to drill into or cut the bone. 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. 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. 05/01/17. A NUsurface implant doesnt burn any bridges, Arbel said. 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. Written submissions may be made to the contact person on or before April 4, 2023. If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. 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. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. His pain started following that partial meniscectomy. 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. 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 NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee 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. 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. 5214, Silver Spring, MD 20993-0002, [email protected], 301-636-0512, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). endstream endobj 791 0 obj <>stream 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. 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. 3 ). The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. 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. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? 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. Last Meniscus Implant Treated in Clinical Trial - Active Implants The implant is made from a medical-grade plastic. According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. At Last an Artificial Meniscus - John Patrick 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]. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. They act as shock absorbers and stabilize the knee. h[n7OYEI 0Mf Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews MD+DI Online is part of the Informa Markets Division of Informa PLC. 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. h24U0P6A Progressively, the implant will form a customized fit to the patients knee contour. 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. 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. Investigational device. The device is approved in Europe under CE regulations and in Israel. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. app. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. sU, Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams 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. 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. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. Before sharing sensitive information, make sure you're on a federal government site. The Company believes the NUsurface device could treat hundreds of thousands of patients per year whose previous partial meniscectomy surgery was not successful and yet are not ready or old enough for knee arthroplasty. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. FDA Grants Breakthrough Device Designation for NUsurface Implant 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.
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