nusurface meniscus implant fda approval

NUsurface Implant Registry - Full Text View - ClinicalTrials.gov The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 787 0 obj <>stream This program is designed to ensure patients and healthcare providers have more timely access to vital devices. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. 1. The device is currently marketed in Belgium, Germany, Italy, and Israel. 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. Meniscus Clinical Trial I Ohio State Sports Medicine Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 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. Time allotted for each presentation may be limited. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, Davis said. Previous Post First NUsurface Meniscus Implant - Active Implants endstream endobj 792 0 obj <>stream The artificial meniscus is made from medical-grade polymer and other unique materials. However, it could still be years before this procedure is available in the United States. The procedure was performed as part of a pivotal trial to demonstrate the superiority of the NUsurface Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. 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. TEAMS (captions):teams.microsoft.com/meetup. But, we need a longer follow-up to verify it.. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. 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. After this procedure, patients no longer need prolonged protected weight bearing or braces. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. 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. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. 2023 Healthline Media LLC. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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. Contact us today for more information about the NUsurface Meniscus Implant. There arent many options for these patients, unfortunately. Active Implants which specializes in orthopedic solutions and has operations in Memphis, Tennessee, the Netherlands, and Israel has begun marketing their product in the Middle East. endstream endobj 791 0 obj <>stream 3 ). Active Implants wins breakthrough nod for NUsurface knee implant We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY ZhIU#F|;@72s## @Fia( $shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. The contact person will notify interested persons regarding their request to speak by March 28, 2023. 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. 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). 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 These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. As I wrote in . The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. All statements regarding Active Implants expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as expects, reaffirms, intends, anticipates, plans, believes, seeks, estimates, optimistic, or variations of such words and similar expressions, are forward-looking statements. 2). 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. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. 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. Arbel is optimistic about the effectiveness of the new implant. 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. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. CAUTION FDA Approval for IDE Clinical Trial of the NUsurface Meniscus Implant He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. 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.. 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 does not assume any obligation to publicly update or revise any forward-looking statements for any reason. 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. @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a "cC*RS 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 new procedure is a lot simpler than other options. %PDF-1.6 % Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. September 20, 2019 By Sean Whooley. FDA NON-Voting Questions For more information, visit www.activeimplants.com. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. The Breakthrough Device Designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, said Ted Davis, president and CEO of Active Implants. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. 05/01/17. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. endstream endobj 788 0 obj <>stream Arbels patient, a 54-year-old man, suffered from knee pain after a surgeon removed about one-third of his medial meniscus, which was torn during athletic activity. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. NUSurface meniscal implant The polycarbonate-urethane (PCU), interpositional meniscus replacement implant (NUsurface Meniscus Implant-Active Implants, LLC) is a novel alternative to the existing approaches to meniscus replacement attempting to match these attributes ( Fig. Before sharing sensitive information, make sure you're on a federal government site. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. The notification should include a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 27, 2023. Progressively, the implant will form a customized fit to the patients knee contour. 3 Things You Should Know Before Having Knee - Active Implants 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 Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. Healthline Media does not provide medical advice, diagnosis, or treatment. 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. 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. Active Implants partners with Geistlich Pharma for NUsurface The NUsurface meniscus implant is designed 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, said the company in a news release. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. Investors are cautioned that actual events or results may differ from Active Implants expectations. First 'Artificial Meniscus' Wins FDA Breakthrough Device Designation, Medtech in a Minute: A Shocking M&A Rumor, and More, Medtech in a Minute: Medtronic Layoffs, and More. The Venus trial is the culmination of years of development and testing of the NUsurface and follows a prospective, multi-center trial that enrolled 128 patients in centers in Europe and Israel. Dr. Hershman is Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York and team doctor of the New York Jets. The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 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. Clinical studies outside the USA have shown that the NUsurface Meniscus Implant results in significant pain relief and restoration of function compared to currently available treatments, said Henry Klyce, Chairman and CEO of Active Implants. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. 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, The Ohio State University Wexner Medical Center, https://clinicaltrials.gov/show/NCT02108496. The device is approved in Europe under CE regulations and in Israel. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. NUsurface - Rimoni Industries The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. Registered in England and Wales. r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. FDA Grants Breakthrough Designation to 'Artificial Meniscus 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 general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! Most people can begin to walk normally in about 3 months, he added. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. J Bone Joint Surg Am. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. Can Manufacturing Technology Enhance Healthcare? 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. New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 2022 Active Implants. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. The product is approved in Europe under CE regulations and in Israel. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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 NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. The SUN and VENUS U.S. clinical trials completed enrollment in June 2018, and Active Implants is expecting to file for regulatory approval in the U.S. in the next two years. Active Implants is privately held with headquarters in Memphis, Tennessee. FDA is committed to the orderly conduct of its advisory committee meetings. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. 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. 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. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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. 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 The products listed here include some of the newest medical technology available. Investigational device. AGENCY: Food and Drug Administration, HHS. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. First polymer-based meniscus implant granted expedited review by FDA 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. The .gov means its official.Federal government websites often end in .gov or .mil. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. 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:

. 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 . Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. Get tips from Ohio State experts right to your inbox. His pain started following that partial meniscectomy. First FDA Approved Artificial Meniscus - Medical Automation Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ 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 medial meniscus replacement is said to mimic the function of the natural meniscus and treat pain by redistributing loads transmitted across the knee joint. . This new program is designed to expedite the development and review process for medical devices that are innovative or offer new technology for people whose conditions are life threatening or irreversibly debilitating. Knee Pain Treatment in the Netherlands - Active Implants An estimated 750,000 such procedures are performed each year. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief . The meeting will be open to the public. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. An official website of the United States government, : FDA Breakthrough Device Designation Given To Active Implants For 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. FDA Grants Breakthrough Device Designation for NUsurface Implant Two clinical trials are scheduled in the United States right now. Final approval by the FDA is expected this year. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in

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