The device is approved in Europe under CE regulations and in Israel. 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 . FDA NON-Voting Questions . Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. 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. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. 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 . The artificial meniscus is made from medical-grade polymer and other unique materials. 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. 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. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Number 8860726. 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. 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. 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. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
Meniscal substitution, a developing and long-awaited demand hU[O@+!d&DE5. app.2). 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. 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. 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. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. Arbel is optimistic about the effectiveness of the new implant. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 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. 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. 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. As I wrote in . 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. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. 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. 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 implant is made from polycarbonate-urethane (PCU) a medical grade plastic.
. 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. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. The device is currently marketed in Belgium, Germany, Italy, and Israel. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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. "In particular, it [is] seeking FDA approval of its NUsurface meniscus implant which is the first 'artificial meniscus'and intended to fill the gap between minimally invasive meniscus repair and total knee replacement.". 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 . Download : Download high-res image (115KB) '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. Once the meniscus is damaged, pain often sets in and can lead to arthritis and the need for knee replacement surgery, saysChristopher Kaeding, MD, (pictured left) the executive director of Ohio State Sports Medicine and the surgeon who implanted the device.This meniscal implant fills a gap in our treatment for those with meniscus injuries.. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. "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. Time allotted for each presentation may be limited. For more information, visit www.activeimplants.com. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. The other is expected to be completed in 2023. Lines and paragraphs break automatically. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint .
FDA Grants Breakthrough Device Designation for NUsurface Implant The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. Currently, an estimated 720,000 patients undergo knee replacement surgery yearly.
Meniscus Clinical Trial I Ohio State Sports Medicine The implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. The U.S. Food and Drug Administration has granted "breakthrough.
NUsurface Implant Registry - Full Text View - ClinicalTrials.gov sU,
Informa Markets, a trading division of Informa PLC. The .gov means its official.Federal government websites often end in .gov or .mil. 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 contact person will notify interested persons regarding their request to speak by March 28, 2023. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496.
Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. endstream
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First polymer-based meniscus implant granted expedited review by FDA 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. 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. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. Investors are cautioned that actual events or results may differ from Active Implants expectations.
Recently-Approved Devices | FDA 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. It is made from medical-grade polymer and, as a result of its unique materials, composite structure, and design, does not require fixation to bone or soft tissues. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. J+XWcE2+mNG^Ni44y!RC!J4l]
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Press Releases | Active Implants | Orthopedic Implant Solutions The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone.
Preliminary Results From a US Clinical Trial of a Novel - PubMed Active Implants LLC, a developer of orthopedic implant solutions for joint preservation, said its NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from 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. Active Implants Appoints Ted Davis President and Chief Executive Officer. 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. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 02/22/17. `A#X/hC
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European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. 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:
. 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 Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. 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. FDA NON-Voting Questions The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The next day he started physiotherapy to gain full range of movement.. . After the surgery, my patient started to walk with the aid of crutches, Arbel said. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm '
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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 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. FDA is committed to the orderly conduct of its advisory committee meetings. September 20, 2019 By Sean Whooley. AGENCY: Food and Drug Administration, HHS. endstream
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Before sharing sensitive information, make sure you're on a federal government site. But, we need a longer follow-up to verify it.. If approved, it will be the first artificial meniscus in the United States. 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 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. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. 2022 Active Implants. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. 2022 Active Implants. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. FDA Grants Breakthrough Designation to 'Artificial Meniscus Final approval by the FDA is expected this year. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 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 artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. 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. 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. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, Davis said. Contact us today for more information about the NUsurface Meniscus Implant. The .gov means its official.Federal government websites often end in .gov or .mil. However, it could still be years before this procedure is available in the United States.