nusurface meniscus implant fda approval

As I wrote in . This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. 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 contact person will notify interested persons regarding their request to speak by March 28, 2023. " [It] is designed for patients with persistent knee pain following medial meniscus surgery. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 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. 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. There arent many options for these patients, unfortunately. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. Agar said in a press release that many people who get meniscal repairs later experience pain. 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 . CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. At Last an Artificial Meniscus - John Patrick Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD No need to drill into or cut the bone. 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. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. %PDF-1.6 % Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. "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.". The implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams The new procedure is a lot simpler than other options. Biomaterials for meniscus and cartilage in knee surgery: state of the According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. hU[O@+!d&DE5. 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. 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. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' 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. Download : Download high-res image (115KB) 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. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 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. Web page addresses and e-mail addresses turn into links automatically. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. Written submissions may be made to the contact person on or before April 4, 2023. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews Patient Population: . The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. We look forward to working closely with the FDA to expedite the review process for the NUsurface Implant 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., This will be significant for this patient population, who often dont have good treatment options, said Elliott Hershman, MD, practicing orthopedic surgeon and medical director for the NUsurface clinical trials. Investors are cautioned that actual events or results may differ from Active Implants expectations. 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.. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. TEAMS (captions):teams.microsoft.com/meetup. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. h243Q0Pw/+Q0L)64 )Ic0i 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. Scroll down and select the appropriate advisory committee meeting link. 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 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.. The medial meniscus replacement mimics the . The device is a polymeric disc-shaped device implanted in the medial compartment of First FDA Approved Artificial Meniscus - Medical Automation x{_w X& G These conditions, which affect quality of life, can eventually lead to the need for knee replacement 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 U.S. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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 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. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. Informa Markets, a trading division of Informa PLC. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. Surgery is usually only necessary for severe. Seven clinical sites in the United States are currently enrolling patients in the study, which is called the VENUS-trial (Verification of the Effectiveness of the NUsurface System). 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. 2022 Active Implants. Recently-Approved Devices | FDA Number 8860726. 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. 1. 2022 Active Implants. 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. We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. FDA Grants Breakthrough Device Designation for Artificial Meniscus endstream endobj 790 0 obj <>stream ^>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? FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. 3 ). Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. Before sharing sensitive information, make sure you're on a federal government site. Time allotted for each presentation may be limited. 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.. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. Get tips from Ohio State experts right to your inbox. Lines and paragraphs break automatically. All rights reserved. The meeting will be open to the public. 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. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. 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. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. 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 . As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. 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.. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. See additional information. 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. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Michael Keenan, Chief Financial Officer at 901 762-0352 or Lex R. Giltaij, M.D., M.B.A., President and Chief Operating Officer of Active Implants at +31 (343) 200 140, or email: info@activeimplants.com or visit: www.activeimplants.com. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. 787 0 obj <>stream The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. You may have to refresh your browser before logging on. Active Implants is privately held with headquarters in Memphis, Tennessee. First polymer-based meniscus implant granted expedited review by FDA

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