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The agency has been rapidly accepting devices into this pathway this year. 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. 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. 2). Informa Markets, a trading division of Informa PLC. 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. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. sU,
The device is approved in Europe under CE regulations and in Israel. The first is expected to be completed sometime next year. 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 Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 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. 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 . Our website services, content, and products are for informational purposes only. The product is approved in Europe under CE regulations and in 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. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. FDA Grants Breakthrough Designation to 'Artificial Meniscus 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. Recently-Approved Devices | FDA 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief Study design: Cohort study; Level of evidence, 2. Patient Population: . People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. Biomaterials for meniscus and cartilage in knee surgery: state of the Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. Download : Download high-res image (115KB) Exclusion Criteria: FDA Grants Breakthrough Device Designation for NUsurface Implant @yot-S7]X4w7&pD2)>`*lQ4DBit-0
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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 . First polymer-based meniscus implant granted expedited review by FDA The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. The .gov means its official.Federal government websites often end in .gov or .mil. Copyright 2023. Current state of off the shelf scaffolds and implants for meniscal endstream
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This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Subscribe. . 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 is designed to replace the damaged or deteriorating medial (inner) meniscus in your knee while leaving the rest of your knee joint intact. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. September 20, 2019 By Sean Whooley. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. 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. 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. 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. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. The NUsurface is the first artificial meniscus to be marketed in Europe and is currently under review by the U.S. Food and Drug Administration (FDA). The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The mission of Active Implants LLC is to develop orthopaedic implant solutions that integrate with the natural biomechanics of the musculoskeletal system and allow patients to maintain or return to an active lifestyle. For more information, visit www.activeimplants.com. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. hUKo0+:nPK
]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ 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 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. `A#X/hC
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Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. hD h243Q0Pw/+Q0L)64 )Ic0i You may have to refresh your browser before logging on. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. FDA is committed to the orderly conduct of its advisory committee meetings. As I wrote in . We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. 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. 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. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). 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. After this procedure, patients no longer need prolonged protected weight bearing or braces. MD+DI Online is part of the Informa Markets Division of Informa PLC. endstream
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Can Manufacturing Technology Enhance Healthcare? 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.. 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. Previous Post First NUsurface Meniscus Implant - Active Implants What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. Investigational device. All rights reserved. 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.. First FDA Approved Artificial Meniscus - Medical Automation 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. 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. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. 3 ). Knee Pain Treatment in the Netherlands - Active Implants 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. 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. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 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. So, for us, it is very exciting to finally bring the device to people in Israel.. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. 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. 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. 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. 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. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. Active Implants is privately held with headquarters in Memphis, Tennessee. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. 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. Most people can begin to walk normally in about 3 months, he added. 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. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant "cC*RS
The other is expected to be completed in 2023. Press Releases | Active Implants | Orthopedic Implant Solutions 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 . FDA Grants Breakthrough Device Designation for Artificial Meniscus Surgery is usually only necessary for severe. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. 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. 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. app. Please log on 20 minutes before the webcast to test your signal. An estimated 750,000 such procedures are performed each year. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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. After the surgery, my patient started to walk with the aid of crutches, Arbel said. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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. TEAMS (captions):teams.microsoft.com/meetup. 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. A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. FDA NON-Voting Questions We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. The meeting will be open to the public. Investors are cautioned that actual events or results may differ from Active Implants expectations. Limited by United States law to investigational use. [+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. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. No need to drill into or cut the bone. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in Healthline Media does not provide medical advice, diagnosis, or treatment. The device is currently marketed in Belgium, Germany, Italy, and Israel. 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. If approved, it will be the first artificial meniscus in the United States. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. 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. x{_w X& G April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : There is no need for any fixation with sutures, screws, glue, or other stuff. J Bone Joint Surg Am. " [It] is designed for patients with persistent knee pain following medial meniscus surgery. 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. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm '
The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. Scroll down and select the appropriate advisory committee meeting link. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. 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 is currently marketed in Belgium, Germany, Italy, and Israel. MORE, Light-Activated Molecular Machines for Antifungal Therapy, 3D Printing the Outer Blood-Retina Barrier. app.2). The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 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. 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. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the 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. Copyright 2023 The Ohio State University Wexner Medical Center. 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.
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