First polymer-based meniscus implant granted expedited review by FDA 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. 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. 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. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. The Company believes the NUsurface device could treat hundreds of thousands of patients per year whose previous partial meniscectomy surgery was not successful and yet are not ready or old enough for knee arthroplasty. The Company believes the NUsurface device could be used to treat several hundreds of thousands of patients a year whose earlier meniscectomy treatments have not been successful but are not yet candidates for knee arthroplasty. The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant 787 0 obj <>stream Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. After the surgery, my patient started to walk with the aid of crutches, Arbel said. 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 device is approved in Europe under CE regulations and in Israel. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Patient Population: . FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 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 Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. hD The .gov means its official.Federal government websites often end in .gov or .mil. 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 device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. If approved, it will be the first artificial meniscus in the United States. Advisory Committee Calendar, Recalls, Market Withdrawals and Safety Alerts, April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 04/20/2023, https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings, https://www.fda.gov/AdvisoryCommittees/default.htm, https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm, https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm, Common Questions and Answers about FDA Advisory Committee Meetings, Public Conduct During FDA Advisory Committee Meetings, ORDP April 20, 2023 FDA Executive Summary, ORDP April 20, 2023 FDA Non-Voting Questions, ORDP April 20, 2023 NUsurface Executive Summary. endstream endobj 791 0 obj <>stream request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. Last Meniscus Implant Treated in Clinical Trial - Active Implants The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. MEMPHIS, Tenn.(BUSINESS WIRE)Active Implants LLC today announced the first implantation in the United States of the NUsurface Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or deteriorated meniscus. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' 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 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 implant is made from polycarbonate-urethane (PCU) a medical grade plastic. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. 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 potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews 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.
nusurface meniscus implant fda approval
