FDA NON-Voting Questions . 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 device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. Two clinical trials are scheduled in the United States right now. 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. 2). 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. Active Implants partners with Geistlich Pharma for NUsurface 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. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ People who have the surgery typically can go home soon after the operation. The new procedure is a lot simpler than other options. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. . You may have to refresh your browser before logging on. 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. 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 SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. 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. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. endstream endobj 792 0 obj <>stream 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. So, we think that it will prevent or delay the need for total knee replacement, he said. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. " [It] is designed for patients with persistent knee pain following medial meniscus surgery. Current state of off the shelf scaffolds and implants for meniscal A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. 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 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. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief 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 Appoints Ted Davis President and Chief Executive Officer. 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. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. Agar said in a press release that many people who get meniscal repairs later experience pain. Evaluation of performance defined as NUsurface Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 60 months post-implantation, as measured by KOOS Pain and KOOS 5 Eligibility Criteria Go to Information from the National Library of Medicine The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. 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. 3 Things You Should Know Before Having Knee - Active Implants Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. h[n7OYEI 0Mf A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Surgery is usually only necessary for severe. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. 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. 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. Arbel is optimistic about the effectiveness of the new implant. Last Meniscus Implant Treated in Clinical Trial - 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, : 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 first is expected to be completed sometime next year. 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. 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.. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in 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 . 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 . 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. "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. Active Implants LLC, a privately held, multi-national company, is headquartered in Memphis, Tennessee USA, with additional offices in Driebergen, The Netherlands, and Netanya, Israel. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Investors are cautioned that actual events or results may differ from Active Implants expectations. 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). 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 next day he started physiotherapy to gain full range of movement.. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Web page addresses and e-mail addresses turn into links automatically. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. 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. Progressively, the implant will form a customized fit to the patients knee contour. 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. An estimated 750,000 such procedures are performed each year. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. All rights reserved. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. Study design: Cohort study; Level of evidence, 2. 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. 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 . After this procedure, patients no longer need prolonged protected weight bearing or braces. 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.