FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 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.. We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. NUSurface meniscal implant The polycarbonate-urethane (PCU), interpositional meniscus replacement implant (NUsurface Meniscus Implant-Active Implants, LLC) is a novel alternative to the existing approaches to meniscus replacement attempting to match these attributes ( Fig. The initial surgery took place during an FDA-approved trial of the NUsurface Meniscus comparing it to the current standard of care for patients with persistent knee pain following meniscus surgery. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. `A#X/hC
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The .gov means its official.Federal government websites often end in .gov or .mil. Surgery is usually only necessary for severe. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. [It] is designed for patients with persistent knee pain following medial meniscus surgery. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. Press Releases | Active Implants | Orthopedic Implant Solutions 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. People who have the surgery typically can go home soon after the operation. Arbel is optimistic about the effectiveness of the new implant. Investors are cautioned that actual events or results may differ from Active Implants expectations. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. 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. 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.. 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. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. 3 ). Informa Markets, a trading division of Informa PLC. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. 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. 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. 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. 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. As I wrote in . Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. 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. Last Meniscus Implant Treated in Clinical Trial - Active Implants 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. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. 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. Previous Post First NUsurface Meniscus Implant - Active Implants The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. Time allotted for each presentation may be limited. Subscribe. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. 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. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. 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. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Our website services, content, and products are for informational purposes only. First FDA Approved Artificial Meniscus - Medical Automation Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. FDA NON-Voting Questions The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. Therefore, you should always check the Agencys website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. 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. 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. J Bone Joint Surg Am. app.2). Healthline Media does not provide medical advice, diagnosis, or treatment. You can find additional information at the links below: PMA Approvals: Monthly listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway.These . 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. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. Copyright 2023. First polymer-based meniscus implant granted expedited review by FDA The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. The site is secure. @yot-S7]X4w7&pD2)>`*lQ4DBit-0
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The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. 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. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. [+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. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. 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. There arent many options for these patients, unfortunately. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews 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 . At Last an Artificial Meniscus - John Patrick Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Recently-Approved Devices | FDA According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. sU,
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. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. "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. 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. September 20, 2019 By Sean Whooley. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. The medial meniscus replacement mimics the . 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 . 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. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or avoid a knee replacement surgery altogether, Kaeding says. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. 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. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. 2022 Active Implants. 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. "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. Active Implants wins breakthrough nod for NUsurface knee implant People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. 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 "VENUS"-study (Verification of the Effectiveness of the . Investigational device. 2022 Active Implants. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. New or current treatment with the NUsurface meniscus implant Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry. . 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. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. 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 NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. FDA NON-Voting Questions . 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 U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. First NUsurface Meniscus Implanted for Knee Osteoarthritis app. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 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.