nusurface meniscus implant fda approval

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. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. 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. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. Surgery is usually only necessary for severe. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. Download : Download high-res image (115KB) 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. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! MD+DI Online is part of the Informa Markets Division of Informa PLC. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. %PDF-1.6 % What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. endstream endobj 792 0 obj <>stream app.2). 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 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). h243Q0Pw/+Q0L)64 )Ic0i I look forward to the opportunity to offer this exciting new technology to my patients when it is available in the U.S., stated Elliott Hershman, M.D., Chief Medical Advisor to Active Implants. Web page addresses and e-mail addresses turn into links automatically. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. Lines and paragraphs break automatically. 2022 Active Implants. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. ^>T&.~Tp>4wN F8*U#o"AQb`rD9@*hD 39xa -lMF{';j{vrwTfD!h>(tZ}[!OFR]x69R]LWxJ(.v: W!-n:vpy!J[=>nQo,)*(~eCd:e6. a:;z3|/ ']i N2uy^ .rGX^ob3IJcA1U}A0X*p!\h"&UL,%_ebW@E#0~Q_("J_CjEG\C}c7`,zud? Ted Davis, president and CEO of Memphis, TN-basedActive Implants, said the company expects to have the data required for an FDA submission next year. 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). 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 device is currently marketed in Belgium, Germany, Italy, and Israel. 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. 05/01/17. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. So, we think that it will prevent or delay the need for total knee replacement, he said. 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. 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. The contact person will notify interested persons regarding their request to speak by March 28, 2023. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. 2022 Active Implants. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. 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 LLC Secures First Tranche of a $40 Million Equity Financing. There is no need for any fixation with sutures, screws, glue, or other stuff. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. 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. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. endstream endobj 789 0 obj <>stream 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. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. FDA is committed to the orderly conduct of its advisory committee meetings. Therefore, you should always check the Agencys website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. 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. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. So, for us, it is very exciting to finally bring the device to people in Israel.. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. 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. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. 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. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. 1. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. hD The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. Investigational device. 03/16/17. 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. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. Copyright 2023. 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. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. All rights reserved. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. Agar said in a press release that many people who get meniscal repairs later experience pain. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. Therefore, you should always check the agencys website or call the committees Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting. All rights reserved. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. Most people can begin to walk normally in about 3 months, he added. 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 NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. 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. 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. sU, 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. If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. app. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. September 20, 2019 By Sean Whooley. 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. 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. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. New or current treatment with the NUsurface meniscus implant Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the Registry. Can Manufacturing Technology Enhance Healthcare? The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. hU[O@+!d&DE5. 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. 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. Investors are cautioned that actual events or results may differ from Active Implants expectations. On April 20, 2023, the committee will discuss, make recommendations, and vote on clinical information related to the De Novo request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. 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.. People who have the surgery typically can go home soon after the operation. Scroll down and select the appropriate advisory committee meeting link. Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. 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. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. They act as shock absorbers and stabilize the knee. 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. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. TEAMS (captions):teams.microsoft.com/meetup. 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. To evaluate the preliminary results from 2 ongoing trials that are evaluating the safety and effectiveness of a synthetic polymer meniscal implant (NUsurface; Active Implants, LLC). The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. . 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. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. Arbel is optimistic about the effectiveness of the new implant. . 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 device is approved in Europe under CE regulations and in Israel. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. 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 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. 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 . The products listed here include some of the newest medical technology available. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed . 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. 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. 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. SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Investors are cautioned that actual events or results may differ from Active Implants expectations. 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 meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. 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. An estimated 750,000 such procedures are performed each year. 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. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. 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.
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