Progressively, the implant will form a customized fit to the patients knee contour. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ CAUTION We review the different surgical techniques to repair or reconstruct an unhealthy joint, and discuss when doctors may choose one technique over. Active Implants Appoints Ted Davis President and Chief Executive Officer. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. 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 . See additional information. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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 implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. There arent many options for these patients, unfortunately. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. Please note: The lists in this section do not include every new medical device that has been cleared or approved for sale in the US. Written submissions may be made to the contact person on or before April 4, 2023. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. 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. 2022 Active Implants. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. 3 Things You Should Know Before Having Knee - Active Implants 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. 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. After this procedure, patients no longer need prolonged protected weight bearing or braces. The contact person will notify interested persons regarding their request to speak by March 28, 2023. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. endstream endobj 789 0 obj <>stream All rights reserved. All rights reserved. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The artificial medial meniscus implant NUsurface meniscus implant (Active Implants, USA) is a non-anchored femur conforming implant, which is designed to sit within the medial compartment, between . This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. 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 VENUS-study (Verification of the Effectiveness of the NUsurface System) is a prospective, randomized, multicenter study to demonstrate superiority of the NUsurface Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. 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. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. NUsurface - Rimoni Industries 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. 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. 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. FDA NON-Voting Questions . The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. 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. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. 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. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. 1. About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to help relieve knee pain and restore function similar to that of the healthy meniscus. Im pleased to hear the FDA will prioritize its review of this important new device and possibly make this therapy available for use by other knee surgeons for their American patients., The meniscus is a tissue pad between the thigh and shin bones. Lines and paragraphs break automatically. MEMPHIS, Tenn. September 19, 2019 Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. An official website of the United States government, : The NUsurface Meniscus Implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. 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. Copyright 2023 The Ohio State University Wexner Medical Center. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. There haven't been many options for these patients, unfortunately. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. 787 0 obj <>stream And, in case the implant doesnt fit the patient, which very rarely happens, it can be taken out and the knee is back to the same situation as before the implantation.. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " h24U0P6A This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a Agar said in a press release that many people who get meniscal repairs later experience pain. "If this meniscal implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries." Kaeding said. Knee Pain Treatment in the Netherlands - Active Implants 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 NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. (T)fu;$@%PXGZy,/y bB>d0{axN6?%:~%d4}^$}d}_D*-)?%edRx,@0ud@#xgYB{'B`J!F0CxJ0:*iCQ}.cb1qIG%: Biomaterials for meniscus and cartilage in knee surgery: state of the They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. His pain started following that partial meniscectomy. 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. 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. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. 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. %PDF-1.6 % . 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.. Recently-Approved Devices | FDA Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. Ill also advise patients to have the implant immediately after a partial medial meniscectomy to prevent degeneration of their cartilage., After more than 10 years in clinical trials, it is an exciting time to finally be able to make the NUsurface Implant available to Israeli patients, he said, according to prepared remarks. Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. 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. The site is secure. So, we think that it will prevent or delay the need for total knee replacement, he said. Surgery is usually only necessary for severe. 2022 Active Implants. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. 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. Current state of off the shelf scaffolds and implants for meniscal People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus.
Nascar Merchandise Sales By Driver 2020,
Salisbury Athletics Staff Directory,
Fox Theater View From My Seat,
Articles N