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 NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. As I wrote in . `A#X/hC
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E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! This program is designed to ensure patients and healthcare providers have more timely access to vital devices. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Arbel is optimistic about the effectiveness of the new implant. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. First polymer-based meniscus implant granted expedited review by FDA ^>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? Our website services, content, and products are for informational purposes only. 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. The first is expected to be completed sometime next year. 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. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? 1. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. Answers to commonly asked questions, including information regarding special accommodations due to a disability, may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. All rights reserved. The implant is made from a medical-grade plastic. The artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. Final approval by the FDA is expected this year. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. If those trials prove to be successful, the device would still need to be approved by the FDA before it could be available in the United States. 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 Appoints Ted Davis President and Chief Executive Officer. Before sharing sensitive information, make sure you're on a federal government site. 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. The device is currently marketed in Belgium, Germany, Italy, and Israel. Scroll down and select the appropriate advisory committee meeting link. 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. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. Surgery is usually only necessary for severe. 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. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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. "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. endstream
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hU[O@+!d&DE5. x{_w X& G NUsurface Implant Registry - Full Text View - ClinicalTrials.gov The .gov means its official.Federal government websites often end in .gov or .mil. 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. FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. 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. FDA Grants Breakthrough Designation to 'Artificial Meniscus Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. 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 designation allows an expedited review of the NUsurface meniscus implant from Active Implants. NUsurface - Rimoni Industries 5214, Silver Spring, MD 20993-0002, Akinola.Awojope@fda.hhs.gov, 301-636-0512, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : 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] is designed for patients with persistent knee pain following medial meniscus surgery. We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. 2022 Active Implants. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. The device is approved in Europe under CE regulations and in Israel. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial 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. TEAMS (captions):teams.microsoft.com/meetup. The new procedure is a lot simpler than other options. Exclusion Criteria: FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. 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]. FDA NON-Voting Questions Meniscal substitution, a developing and long-awaited demand MD+DI Online is part of the Informa Markets Division of Informa PLC. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. 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. "cC*RS
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. 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 implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. Biomaterials for meniscus and cartilage in knee surgery: state of the is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. 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 artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 787 0 obj
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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. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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.. 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 Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. Investors are cautioned that actual events or results may differ from Active Implants expectations. There arent many options for these patients, unfortunately. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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.. 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 agency has been rapidly accepting devices into this pathway this year. endstream
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h[n7OYEI 0Mf 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: . The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. 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. No need to drill into or cut the bone. Preliminary Results From a US Clinical Trial of a Novel - PubMed 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 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). 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.. The meniscus is a fibrocartilage pad located between the thigh and shin bones, and once its damaged has a very limited healing potential. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Can Manufacturing Technology Enhance Healthcare? Please log on 20 minutes before the webcast to test your signal. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. Press Releases | Active Implants | Orthopedic Implant Solutions Written submissions may be made to the contact person on or before April 4, 2023. 11.1 Panel Non -Voting Questions . 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 artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. "If this meniscal implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries." Kaeding said. The medial meniscus replacement mimics the . The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Arbel is encouraged by the results of studies of the new artificial meniscus. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. (T)fu;$@%PXGZy,/y bB>d0{axN6?%:~%d4}^$}d}_D*-)?%edRx,@0ud@#xgYB{'B`J!F0CxJ0:*iCQ}.cb1qIG%: Web page addresses and e-mail addresses turn into links automatically. An estimated 750,000 such procedures are performed each 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. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. FDA Grants Breakthrough Device Designation for NUsurface Implant 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. The artificial meniscus is made from medical-grade polymer and other unique materials. 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. 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. Agar said in a press release that many people who get meniscal repairs later experience pain. A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 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. 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. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. 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 .