FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. 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 U.S. Current state of off the shelf scaffolds and implants for meniscal The medial meniscus replacement mimics the . Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 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. [+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. ^>T&.~Tp>4wN F8*U#o"AQb`rD9@*hD 39xa -lMF{';j{vrwTfD!h>(tZ}[!OFR]x69R]LWxJ(.v: W!-n:vpy!J[=>nQo,)*(~eCd:e6. a:;z3|/ ']i N2uy^ .rGX^ob3IJcA1U}A0X*p!\h"&UL,%_ebW@E#0~Q_("J_CjEG\C}c7`,zud? The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The contact person will notify interested persons regarding their request to speak by March 28, 2023. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. All rights reserved. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. Patient Population: . Arbel is encouraged by the results of studies of the new artificial meniscus. 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 NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . Biomaterials for meniscus and cartilage in knee surgery: state of the 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. All rights reserved. Get tips from Ohio State experts right to your inbox. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. There haven't been many options for these patients, unfortunately. 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 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. 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. 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. 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 implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 27, 2023. Dr. Hershman said, The NUsurface Meniscus Implant is a novel, composite polymer implant, which is used to treat knee patients who have pain and disability arising from osteoarthritis caused by a previous meniscectomy, meniscus dysfunction or insufficiency. There arent many options for these patients, unfortunately. app. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. 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. 3 ). The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Surgery is usually only necessary for severe. As I wrote in . The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. hD The product is approved in Europe under CE regulations and in Israel. 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. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. FDA Grants Breakthrough Designation to 'Artificial Meniscus An estimated 750,000 such procedures are performed each year. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Before sharing sensitive information, make sure you're on a federal government site. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. See additional information. 2). A NUsurface implant doesnt burn any bridges, Arbel said. 2022 Active Implants. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The meeting will be open to the public. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD 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. Advanced Orthopedics & Sports Medicine Specialists Performs First. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. Number 8860726. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. Two clinical trials are scheduled in the United States right now. The next day he started physiotherapy to gain full range of movement.. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. Study design: Cohort study; Level of evidence, 2. AGENCY: Food and Drug Administration, HHS. We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. 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 FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. "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.". Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 2023 Healthline Media LLC. Earlier this year Active Implants gained some attention from Needham & Co.'s Mike Matson, who included the company on a list of interesting private medtech companies. 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. Recently-Approved Devices | FDA The site is secure. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). TEAMS (captions):teams.microsoft.com/meetup. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. endstream endobj 789 0 obj <>stream The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. 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. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. FDA intends to make background material available to the public no later than 2 business days before the meeting. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. h24U0P6A The products listed here include some of the newest medical technology available. app.2). 05/01/17. Informa Markets, a trading division of Informa PLC. If approved, it will be the first artificial meniscus in the United States. 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. 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. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. Medical Design & Manufacturing (MD&M) East 2023, New M&A Rejuvenates Robotics Sector in Medtech, Nanox.AI Expands Reach Through New Partnership, ZimVie's Mobi-C Wins Reimbursement in France. . The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' Factors that may affect the actual results achieved by Active Implants include, without limitation, the ability of Active Implants to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of Active Implants to integrate purchased businesses, R&D capabilities, infrastructure and employees. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. People who have the surgery typically can go home soon after the operation. . Meniscus Replacements in Colorado with NUsurface Meniscus Implant. It is made from medical-grade polymer, and, owing to its materials, composite structure, and design, does not require fixation to bone or soft tissues, according to the company. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief The implant is made from a medical-grade plastic. 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. FDA is committed to the orderly conduct of its advisory committee meetings. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. 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. An official website of the United States government, : Active Implants Enters Partnership with Geistlich Pharma AG for Written submissions may be made to the contact person on or before April 4, 2023. %PDF-1.6 % sU, 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 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. 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.. So, we think that it will prevent or delay the need for total knee replacement, he said. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. Preliminary Results From a US Clinical Trial of a Novel - PubMed The agency has been rapidly accepting devices into this pathway this year. 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. First polymer-based meniscus implant granted expedited review by FDA NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants Active Implants partners with Geistlich Pharma for NUsurface 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 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. 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. Progressively, the implant will form a customized fit to the patients knee contour. The first is expected to be completed sometime next year. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. Limited by United States law to investigational use. 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 . 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 First NUsurface Meniscus Implanted for Knee Osteoarthritis The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. 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. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
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