For more information, visit www.activeimplants.com. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. 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. 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. The device is made from medical grade plastic and, as a result of its unique materials, composite structure, and design, does not require fixation to bone or soft tissues. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. 02/22/17. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline Copyright 2023. 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). April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the 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 . The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. September 20, 2019 By Sean Whooley. The product is approved in Europe under CE regulations and in Israel. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. 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. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 2). "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 does not assume any obligation to publicly update or revise any forward-looking statements for any reason. Most people can begin to walk normally in about 3 months, he added. endstream endobj 788 0 obj <>stream Subscribe. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. 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. Contact us today for more information about the NUsurface Meniscus Implant. 05/01/17. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. The NUsurface, which is the first artificial meniscus to be marketed in Europe, is currently being reviewed by the US Food and Drug Administration (FDA). DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. 1. So, for us, it is very exciting to finally bring the device to people in Israel.. J Bone Joint Surg Am. The products listed here include some of the newest medical technology available. CAUTION The device is approved in Europe under CE regulations and in Israel. The medial meniscus replacement mimics the . The U.S. Food and Drug Administration has granted "breakthrough. 3 Things You Should Know Before Having Knee - Active Implants Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. 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 . Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. As I wrote in . This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Meniscal substitution, a developing and long-awaited demand Active Implants Appoints Ted Davis President and Chief Executive Officer. 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. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. 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. app.2). FDA Grants Breakthrough Designation to 'Artificial Meniscus 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. 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. 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. Written submissions may be made to the contact person on or before April 4, 2023. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. Investors are cautioned that actual events or results may differ from Active Implants expectations. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. 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 site is secure. Active Implants LLC is a privately held, multi-national company headquartered in Memphis, Tennessee USA with additional offices in Driebergen, The Netherlands, and Netanya, Israel. 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 . FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.
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