nusurface meniscus implant fda approval
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. The NUsurface is designed to replace the damaged or deteriorating medial (inner) meniscus in your knee while leaving the rest of your knee joint intact. "cC*RS
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Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 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. 2022 Active Implants. Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. So, we think that it will prevent or delay the need for total knee replacement, he said. Limited by United States law to investigational use. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. After the surgery, my patient started to walk with the aid of crutches, Arbel said. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The medial meniscus replacement mimics the . Final approval by the FDA is expected this year. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. 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. 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 first is expected to be completed sometime next year. Active Implants is privately held with headquarters in Memphis, Tennessee. A NUsurface implant doesnt burn any bridges, Arbel said. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Active Implants LLC, a developer of orthopedic implant solutions for joint preservation, said its NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). 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 . 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: . 11.1 Panel Non -Voting Questions . 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. 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.. The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. The NUsurface Meniscus Implant was designed to meet the needs of patients too old for meniscus repair and too young for a knee replacement., For the past three years, Active Implants has been working with leading knee sports medicine surgeons in Belgium, Italy, Israel, The Netherlands, Sweden and Germany to conduct a prospective controlled, Multi-Center Trial of the NUsurface Meniscus Implant. "In particular, it [is] seeking FDA approval of its NUsurface meniscus implant which is the first 'artificial meniscus'and intended to fill the gap between minimally invasive meniscus repair and total knee replacement.". The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Peter Verdonk, M.D., PhD, an investigator in the Multi-Center trial from Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, said, I am impressed with the results observed to date and believe this technology could represent a new method of treating patients with meniscus problems who are often on a long and painful progression to knee replacement.. The site is secure. The procedure was performed by Christopher Kaeding, M.D., Professor and Executive Director, of OSU Sports Medicine at The Ohio State University Wexner Medical Center in Columbus, OH. Written submissions may be made to the contact person on or before April 4, 2023. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. If approved, it will be the first artificial meniscus in the United States. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. The site is secure. hD [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY
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$shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. Web page addresses and e-mail addresses turn into links automatically. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. app. About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to relieve knee pain and restore function similar to that of the natural healthy meniscus. Exclusion Criteria: Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). Lines and paragraphs break automatically. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. `A#X/hC
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E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. 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. AGENCY: Food and Drug Administration, HHS. endstream
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There haven't been many options for these patients, unfortunately. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, American Academy of Orthopedic Surgeons Annua, Society for Arthroscopy and Joint Surgery / G, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. Agar said in a press release that many people who get meniscal repairs later experience pain. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 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 NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. The device is a polymeric disc-shaped device implanted in the medial compartment of The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. The agency has been rapidly accepting devices into this pathway this year. 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). request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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. 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 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 U.S. Food and Drug Administration has granted "breakthrough. They act as shock absorbers and stabilize the knee. 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 NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. 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. 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. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. You can find additional information at the links below: PMA Approvals: Monthly listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway.These . The NUsurface is a meniscus replacement prosthesis for treating knee pain in patients who have a damaged or dysfunctional meniscus from injury or after previous surgeries have failed. Healthline Media does not provide medical advice, diagnosis, or treatment. So, for us, it is very exciting to finally bring the device to people in Israel.. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. 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. Our website services, content, and products are for informational purposes only. 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. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber.