Arbel is encouraged by the results of studies of the new artificial meniscus. Agar said in a press release that many people who get meniscal repairs later experience pain. But, we need a longer follow-up to verify it.. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. FDA's 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. 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. Subscribe. 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. 2022 Active Implants. Please log on 20 minutes before the webcast to test your signal. Get tips from Ohio State experts right to your inbox. 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. As I wrote in . Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. Active Implants Appoints Ted Davis President and Chief Executive Officer. The U.S. Food and Drug Administration has granted "breakthrough. The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Before sharing sensitive information, make sure you're on a federal government site. endstream endobj 792 0 obj <>stream Knee Pain Treatment in the Netherlands - Active Implants See additional information. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. The device is a polymeric disc-shaped device implanted in the medial compartment of The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. Healthline Media does not provide medical advice, diagnosis, or treatment. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. "Active Implants has commercialized two unique orthopedic implants in Europe with a visible pathway to bring them into the U.S.," Matson noted in his June 2019 report. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. 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 is committed to the orderly conduct of its advisory committee meetings. 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. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. 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. 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. You may have to refresh your browser before logging on. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. 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. Active Implants partners with Geistlich Pharma for NUsurface Surgery is usually only necessary for severe. 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.. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. Ohio State First to Use Plastic Meniscus Implant in FDA Clinical Trial `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. If approved, it will be the first artificial meniscus in the United States. 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. 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. ^>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? Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews 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. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. Christopher Kaeding, MD, discusses a new knee replacement option being piloted at Ohio State. The medial meniscus replacement mimics the . After the surgery, my patient started to walk with the aid of crutches, Arbel said. app. 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 NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the 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. Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. FDA Grants Breakthrough Device Designation for Artificial Meniscus 11.1 Panel Non -Voting Questions . The other is expected to be completed in 2023. 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. endstream endobj 791 0 obj <>stream The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. U.S. patients who continue to suffer fromknee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. 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. 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). @yot-S7]X4w7&pD2)>`*lQ4DBit-0 rMU{L)m6_SQknw@s{m6Hhtx[ /a 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. Current state of off the shelf scaffolds and implants for meniscal 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 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. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. After this procedure, patients no longer need prolonged protected weight bearing or braces. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. 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. 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. 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 NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. 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. 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 medial meniscus replacement is said to mimic the function of the natural meniscus and treat pain by redistributing loads transmitted across the knee joint. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus 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. Previous Post First NUsurface Meniscus Implant - Active Implants Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. FDA Breakthrough Device Designation Given To Active Implants For The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. Web page addresses and e-mail addresses turn into links automatically. The first is expected to be completed sometime next year. Scroll down and select the appropriate advisory committee meeting link. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. 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. [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY ZhIU#F|;@72s## @Fia( $shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. It is made from medical-grade polymer and, as a result of its unique materials, composite structure, and design, does not require fixation to bone or soft tissues. 2022 Active Implants. app.2). The new procedure is a lot simpler than other options. Can Manufacturing Technology Enhance Healthcare? FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. The .gov means its official.Federal government websites often end in .gov or .mil. 2). Final approval by the FDA is expected this year. About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to relieve knee pain and restore function similar to that of the natural healthy meniscus. Medical Design & Manufacturing (MD&M) East 2023, New M&A Rejuvenates Robotics Sector in Medtech, Nanox.AI Expands Reach Through New Partnership, ZimVie's Mobi-C Wins Reimbursement in France. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " There haven't been many options for these patients, unfortunately. Contact us today for more information about the NUsurface Meniscus Implant. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' Time allotted for each presentation may be limited. 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. So, for us, it is very exciting to finally bring the device to people in Israel.. 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 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 is the first artificial meniscus to be marketed in Europe and is currently under review by the U.S. Food and Drug Administration (FDA). The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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 . 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. 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. CAUTION 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. They act as shock absorbers and stabilize the knee. [It] is designed for patients with persistent knee pain following medial meniscus surgery. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. Meniscal substitution, a developing and long-awaited demand Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. 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 two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. FDA intends to make background material available to the public no later than 2 business days before the meeting. h243Q0Pw/+Q0L)64 )Ic0i FDA NON-Voting Questions The site is secure. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. 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. 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. The products listed here include some of the newest medical technology available. 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. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. hU[O@+!d&DE5. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. 1. The Company believes the NUsurface device could be used to treat several hundreds of thousands of patients a year whose earlier meniscectomy treatments have not been successful but are not yet candidates for knee arthroplasty.
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