The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial 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 NON-Voting Questions This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. 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 procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. 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 NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. FDA Grants Breakthrough Designation to 'Artificial Meniscus 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. Get tips from Ohio State experts right to your inbox. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Number 8860726. Right now, Arbel says the only treatment for people who have a painful or degraded meniscus has been pain medications, physiotherapy, and intra-articular injections (directly into the joint) to relieve pain. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. At Last an Artificial Meniscus - John Patrick Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 2023 Healthline Media LLC. h24U0P6A We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. Web page addresses and e-mail addresses turn into links automatically. 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 agency has been rapidly accepting devices into this pathway this year. 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. 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 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. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. 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. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! FDA Breakthrough Device Designation Given To Active Implants 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. 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. 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. Our website services, content, and products are for informational purposes only. FDA is committed to the orderly conduct of its advisory committee meetings. 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. Healthline Media does not provide medical advice, diagnosis, or treatment. The device is approved in Europe under CE regulations and in Israel. 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. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. CAUTION There haven't been many options for these patients, unfortunately. Biomaterials for meniscus and cartilage in knee surgery: state of the So, for us, it is very exciting to finally bring the device to people in Israel.. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. endstream endobj 792 0 obj <>stream 2022 Active Implants. h243Q0Pw/+Q0L)64 )Ic0i The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. "Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement." The implant is made from a medical grade plastic called, polycarbonate-urethane. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. 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 . The .gov means its official.Federal government websites often end in .gov or .mil. "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. 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. If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 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 implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. 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. 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:

. 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 Implant is currently marketed in Belgium, Germany, Italy and Israel. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. Active Implants wins breakthrough nod for NUsurface knee implant 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 is committed to the orderly conduct of its advisory committee meetings. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 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. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. "cC*RS 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. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. 11.1 Panel Non -Voting Questions . MEMPHIS, Tenn. September 19, 2019 Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. hU[O@+!d&DE5. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. Continued pain after repairing meniscus tears is a very common orthopedic problem, and until now, we have not had effective treatment options., Ted Davis, president and CEO of Active Implants, said, Filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement is a large unmet need in the orthopedic market. The NUsurface meniscus implant is designed to provide a new treatment option to the hundreds of thousands of patients who continue to experience persistent knee pain following meniscus surgery, but are too young for total knee replacement, said the company in a news release. The site is secure. The procedure was performed as part of a pivotal trial to demonstrate the superiority of the NUsurface Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. Exclusion Criteria: 3 Things You Should Know Before Having Knee - Active Implants endstream endobj 790 0 obj <>stream [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY ZhIU#F|;@72s## @Fia( $shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. 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. 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. Limited by United States law to investigational use. MD+DI Online is part of the Informa Markets Division of Informa PLC. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. 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. Agar said in a press release that many people who get meniscal repairs later experience pain. Written submissions may be made to the contact person on or before April 4, 2023. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. The medial meniscus replacement mimics the . The next day he started physiotherapy to gain full range of movement.. Scroll down and select the appropriate advisory committee meeting link. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). They act as shock absorbers and stabilize the knee. You may have to refresh your browser before logging on. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. First polymer-based meniscus implant granted expedited review by FDA TEAMS (captions):teams.microsoft.com/meetup. 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). After the surgery, my patient started to walk with the aid of crutches, Arbel said. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. 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]. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. The device is a polymeric disc-shaped device implanted in the medial compartment of Michael Keenan, Chief Financial Officer at 901 762-0352 or Lex R. Giltaij, M.D., M.B.A., President and Chief Operating Officer of Active Implants at +31 (343) 200 140, or email: info@activeimplants.com or visit: www.activeimplants.com. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. 03/16/17. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 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). NUsurface Implant Registry - Full Text View - ClinicalTrials.gov Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings. Two clinical trials are scheduled in the United States right now. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 2). The .gov means its official.Federal government websites often end in .gov or .mil. The initial surgery took place during an FDA-approved trial ofthe NUsurface Meniscus comparing it to the current standard of care for patients with persistent knee pain following meniscus surgery. Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. 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. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. FDA Grants Breakthrough Device Designation for NUsurface Implant 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. 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. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Copyright 2023 The Ohio State University Wexner Medical Center. Please log on 20 minutes before the webcast to test your signal. 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 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. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " If approved, it will be the first artificial meniscus in the United States. First NUsurface Meniscus Implanted for Knee Osteoarthritis 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. 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. " [It] is designed for patients with persistent knee pain following medial meniscus surgery. 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. Press Releases | Active Implants | Orthopedic Implant Solutions 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. 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. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. FDA intends to make background material available to the public no later than 2 business days before the meeting. "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. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the 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. Johns Hopkins Medicine researchers found that a common surgery known as arthroscopic partial meniscectomy accounted for an estimated two-thirds of all orthopedic knee arthroscopy procedures in older patients in 2016 and that this surgery may not even be that effective. Can Manufacturing Technology Enhance Healthcare? The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. U.S. patients who continue to suffer fromknee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. Investors are cautioned that actual events or results may differ from Active Implants expectations. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. 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. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. %PDF-1.6 % 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. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. FDA Grants Breakthrough Device Designation for Artificial Meniscus app.2). The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. 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. The products listed here include some of the newest medical technology available. 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 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. His pain started following that partial meniscectomy. @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a Current state of off the shelf scaffolds and implants for meniscal The NUsurface Implant was invented and developed in our R&D center in Israel. Informa Markets, a trading division of Informa PLC. 02/22/17. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. The new procedure is a lot simpler than other options. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. The other is expected to be completed in 2023. 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. J Bone Joint Surg Am. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. 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. NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. The device is currently marketed in Belgium, Germany, Italy, and Israel. 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.
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