Time allotted for each presentation may be limited. 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. Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. 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. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in The product is approved in Europe under CE regulations and in Israel. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. 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 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. However, it could still be years before this procedure is available in the United States. 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.The "VENUS"-study (Verification of the Effectiveness of the . There arent many options for these patients, unfortunately. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD 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. 02/22/17. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. 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. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial 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. 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. 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. We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. 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. There haven't been many options for these patients, unfortunately. So, for us, it is very exciting to finally bring the device to people in Israel.. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 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. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. Active Implants is privately held with headquarters in Memphis, Tennessee. Active Implants LLC, a privately held, multi-national company, is headquartered in Memphis, Tennessee USA, with additional offices in Driebergen, The Netherlands, and Netanya, Israel. 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. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Investors are cautioned that actual events or results may differ from Active Implants expectations. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. 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. FDA NON-Voting Questions . Seven clinical sites in the United States are currently enrolling patients in the study, which is called the VENUS-trial (Verification of the Effectiveness of the NUsurface System). The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. %PDF-1.6 % The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 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. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. 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. Copyright 2023. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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. Final approval by the FDA is expected this year. 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. The .gov means its official.Federal government websites often end in .gov or .mil. Active Implants Appoints Ted Davis President and Chief Executive Officer. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. Exclusion Criteria: 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. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The NUsurface Implant was invented and developed in our R&D center in Israel. 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 does not assume any obligation to publicly update or revise any forward-looking statements for any reason. . Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. Investors are cautioned that actual events or results may differ from Active Implants expectations. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. 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. All rights reserved. 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. 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. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. Progressively, the implant will form a customized fit to the patients knee contour. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. 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.
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