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. CAUTION 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.. 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. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. 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 this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. FDA Breakthrough Device Designation Given To Active Implants For [+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. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. Can Manufacturing Technology Enhance Healthcare? Informa Markets, a trading division of Informa PLC. Our website services, content, and products are for informational purposes only. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. The U.S. Food and Drug Administration has granted "breakthrough. For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 2022 Active Implants. The other is expected to be completed in 2023. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. Limited by United States law to investigational use. (T)fu;$@%PXGZy,/y bB>d0{axN6?%:~%d4}^$}d}_D*-)?%edRx,@0ud@#xgYB{'B`J!F0CxJ0:*iCQ}.cb1qIG%: 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. Before sharing sensitive information, make sure you're on a federal government site. At Last an Artificial Meniscus - John Patrick Preliminary Results From a US Clinical Trial of a Novel - PubMed 05/01/17. 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.. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. ^>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? People who have the surgery typically can go home soon after the operation. 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. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Copyright 2023. 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 Press Releases | Active Implants | Orthopedic Implant Solutions 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. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. The 1st Artificial Meniscus has earned the FDA's - OrthoStreams Knee Pain Treatment in the Netherlands - Active Implants Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in FDA is committed to the orderly conduct of its advisory committee meetings. 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. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. 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. 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. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? 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. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. "In particular, it [is] seeking FDA approval of its NUsurface meniscus implant which is the first 'artificial meniscus'and intended to fill the gap between minimally invasive meniscus repair and total knee replacement.". The site is secure. The products listed here include some of the newest medical technology available. 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. 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. The next day he started physiotherapy to gain full range of movement.. 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 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. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or avoid a knee replacement surgery altogether, Kaeding says. 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 function in the medial compartment of a knee in which the medial meniscus has been resected. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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 implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. FDA Grants Breakthrough Device Designation for Artificial Meniscus 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. They act as shock absorbers and stabilize the knee. 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). The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Active Implants partners with Geistlich Pharma for NUsurface h24U0P6A The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Meniscal substitution, a developing and long-awaited demand There haven't been many options for these patients, unfortunately. TEAMS (captions):teams.microsoft.com/meetup. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " endstream endobj 789 0 obj <>stream " [It] is designed for patients with persistent knee pain following medial meniscus surgery. FDA NON-Voting Questions . 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. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. 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. endstream endobj 788 0 obj <>stream An estimated 750,000 such procedures are performed each year.
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