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[It] is designed for patients with persistent knee pain following medial meniscus surgery. There haven't been many options for these patients, unfortunately. We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. NUsurface - Rimoni Industries Copyright 2023. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. 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. endstream endobj 788 0 obj <>stream Web page addresses and e-mail addresses turn into links automatically. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 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. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. 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. 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. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. Our website services, content, and products are for informational purposes only. 03/16/17. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. Recent breakthrough device designations include a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, aninteratrial shunt for heart failure from V-Wave, B. Braun'sdrug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronaryintravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze,and two cancer diagnostic tests. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Investors are cautioned that actual events or results may differ from Active Implants expectations. Agar said in a press release that many people who get meniscal repairs later experience pain. 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 designation allows an expedited review of the NUsurface meniscus implant from Active Implants. If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. FDA Grants Breakthrough Designation to 'Artificial Meniscus Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.