The device is currently marketed in Belgium, Germany, Italy, and Israel. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. The implant, which mimics the function of the natural meniscus, 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.. 03/16/17. 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. app.2). 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. 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. Contact us today for more information about the NUsurface Meniscus Implant. 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). This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. 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. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. All rights reserved. Arbel is optimistic about the effectiveness of the new implant. endstream endobj 788 0 obj <>stream Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 2022 Active Implants. 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. Agar said in a press release that many people who get meniscal repairs later experience pain. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief FDA intends to make background material available to the public no later than 2 business days before the meeting. The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. Final approval by the FDA is expected this year. h24U0P6A 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. Copyright 2023 The Ohio State University Wexner Medical Center. 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. 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.. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : FDA NON-Voting Questions . The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The medial meniscus replacement mimics the . According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. 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. FDA Grants Breakthrough Designation to 'Artificial Meniscus The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. 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 . endstream endobj 790 0 obj <>stream An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. But, we need a longer follow-up to verify it.. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. 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 . We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. The device is a polymeric disc-shaped device implanted in the medial compartment of Active Implants wins breakthrough nod for NUsurface knee implant The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. hU[O@+!d&DE5. For the first time in the U.S., surgeons at The Ohio State University Wexner Medical Center have implanted a plastic device designed to help patients with persistent knee pain due to injured or deteriorating meniscus cartilage. app. Can Manufacturing Technology Enhance Healthcare? 02/22/17. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. 3 ). 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. Please log on 20 minutes before the webcast to test your signal. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial Informa Markets, a trading division of Informa PLC. There is no need for any fixation with sutures, screws, glue, or other stuff. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. 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. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! Limited by United States law to investigational use. 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. Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. 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. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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. 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. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the There haven't been many options for these patients, unfortunately. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? 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 NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. After the surgery, my patient started to walk with the aid of crutches, Arbel said. His pain started following that partial meniscectomy. 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. Advanced Orthopedics & Sports Medicine Specialists Performs First. 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. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The meeting will be open to the public. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. 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. Registered in England and Wales. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. 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. NUsurface Implant Registry - Full Text View - ClinicalTrials.gov 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 . 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. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. Subscribe. 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. First NUsurface Meniscus Implanted for Knee Osteoarthritis Our website services, content, and products are for informational purposes only. FDA is committed to the orderly conduct of its advisory committee meetings. An official website of the United States government, : FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant 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, The Ohio State University Wexner Medical Center, https://clinicaltrials.gov/show/NCT02108496. 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.. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' "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. 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. 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. Written submissions may be made to the contact person on or before April 4, 2023. 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. At Last an Artificial Meniscus - John Patrick %PDF-1.6 % The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 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. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. 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. Current state of off the shelf scaffolds and implants for meniscal No need to drill into or cut the bone. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Following these measures, the person has had to wait until the cartilage has deteriorated severely to the point where the knee needs to be replaced with an artificial implant made of metal and plastic. TEAMS (captions):teams.microsoft.com/meetup. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). 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. 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]. The site is secure. J Bone Joint Surg Am. J+XWcE2+mNG^Ni44y!RC!J4l] YAR "*QG!(a/+:D[tI`0\0414*4(aRabEmM9(C0geD/;83fgS7g9]cA9c 1>hxM5Hd 1#2^kx)h4@VTgFUjmRl=FFYCpTcK.j1.40VV b!40oq06CqU,:M[,fD& $y%.Hj1)#/1L7qIj-l0 0xLJ&R .`eE 3 r;#5515=0`d" 2s,-P udt@MgQ"H%+BRvS 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. FDA is committed to the orderly conduct of its advisory committee meetings. " [It] is designed for patients with persistent knee pain following medial meniscus surgery. After this procedure, patients no longer need prolonged protected weight bearing or braces. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Before sharing sensitive information, make sure you're on a federal government site. First polymer-based meniscus implant granted expedited review by FDA Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. 2022 Active Implants. 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. So, we think that it will prevent or delay the need for total knee replacement, he said. 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. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. 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 meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. 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. Get tips from Ohio State experts right to your inbox. We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. AGENCY: Food and Drug Administration, HHS. endstream endobj 791 0 obj <>stream 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. 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. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. 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. 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. 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. Knee Pain Treatment in the Netherlands - Active Implants September 20, 2019 By Sean Whooley. 05/01/17. endstream endobj 792 0 obj <>stream Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. FDA Grants Breakthrough Device Designation for NUsurface Implant Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. 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 . There arent many options for these patients, unfortunately. 1. The contact person will notify interested persons regarding their request to speak by March 28, 2023. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. 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 . NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The device is approved in Europe under CE regulations and in Israel. The agency has been rapidly accepting devices into this pathway this year. 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. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. The product is approved in Europe under CE regulations and in Israel. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. 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. 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. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. You may have to refresh your browser before logging on. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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 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. Download : Download high-res image (115KB) Copyright 2023. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. Active Implants partners with Geistlich Pharma for NUsurface
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