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. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. FDA Breakthrough Device Designation Given To Active Implants For 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. 3 Things You Should Know Before Having Knee - Active Implants Answers to commonly asked questions, including information regarding special accommodations due to a disability, may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. 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 potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. . Subscribe. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. 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. 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. 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. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. ^>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? endstream endobj 790 0 obj <>stream 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. Active Implants is privately held with headquarters in Memphis, Tennessee. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. 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. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. FDA Grants Breakthrough Designation to 'Artificial Meniscus 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. First NUsurface Meniscus Implanted for Knee Osteoarthritis As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT). 2022 Active Implants. Active Implants Appoints Ted Davis President and Chief Executive Officer. 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. 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. 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. The next day he started physiotherapy to gain full range of movement.. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. 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. "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. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. endstream endobj 792 0 obj <>stream Meniscus Clinical Trial I Ohio State Sports Medicine 3 ). 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. Investigational device. So, for us, it is very exciting to finally bring the device to people in Israel.. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Before sharing sensitive information, make sure you're on a federal government site. 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. 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. TEAMS (captions):teams.microsoft.com/meetup. Preliminary Results From a US Clinical Trial of a Novel - PubMed Informa Markets, a trading division of Informa PLC. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. 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. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. 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. (T)fu;$@%PXGZy,/y bB>d0{axN6?%:~%d4}^$}d}_D*-)?%edRx,@0ud@#xgYB{'B`J!F0CxJ0:*iCQ}.cb1qIG%: 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. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. An official website of the United States government, : The Company believes the NUsurface device could treat hundreds of thousands of patients per year whose previous partial meniscectomy surgery was not successful and yet are not ready or old enough for knee arthroplasty. Arbel is encouraged by the results of studies of the new artificial meniscus. 2022 Active Implants. Download : Download high-res image (115KB) The other is expected to be completed in 2023. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. 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. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. You may have to refresh your browser before logging on. 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 device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Healthline Media does not provide medical advice, diagnosis, or treatment. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. 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. First polymer-based meniscus implant granted expedited review by FDA Number 8860726. According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Investors are cautioned that actual events or results may differ from Active Implants expectations. hU[O@+!d&DE5. NUsurface - Rimoni Industries The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD If approved, it will be the first artificial meniscus in the United States. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. app. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.. 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. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. Surgery is usually only necessary for severe. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. "Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement." The implant is made from a medical grade plastic called, polycarbonate-urethane. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. endstream endobj 788 0 obj <>stream 2022 Active Implants. The NUsurface is designed to replace the damaged or deteriorating medial (inner) meniscus in your knee while leaving the rest of your knee joint intact. 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. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. 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. 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. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the app.2). 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. FDA intends to make background material available to the public no later than 2 business days before the meeting. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery, said Dr. Kaeding. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. [+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. The device is approved in Europe under CE regulations and in Israel. 03/16/17. The new procedure is a lot simpler than other options. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. 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.. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. Agar said in a press release that many people who get meniscal repairs later experience pain. Final approval by the FDA is expected this year. The agency has been rapidly accepting devices into this pathway this year. The meeting will be open to the public. 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 contact person will notify interested persons regarding their request to speak by March 28, 2023. Progressively, the implant will form a customized fit to the patients knee contour. After this procedure, patients no longer need prolonged protected weight bearing or braces. 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. The implant, which mimics the function of the natural meniscus, redistributes loads transmitted across the knee joint. NUsurface Meniscus Implant for Persistent Knee Pain - Active Implants FDA NON-Voting Questions . [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. x{_w X& G The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 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. Active Implants wins breakthrough nod for NUsurface knee 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 implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 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. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. CAUTION "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. 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 . Clinical studies outside the U.S. have demonstrated the potential clinical benefits of our NUsurface Meniscus Implant for patients with early knee osteoarthritis, said Henry Klyce, Chairman and CEO of Active Implants. The U.S. Food and Drug Administration has granted "breakthrough. 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. 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. 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. 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. 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 . Contact us today for more information about the NUsurface Meniscus Implant. Please log on 20 minutes before the webcast to test your signal. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. No need to drill into or cut the bone. The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. The product is approved in Europe under CE regulations and in Israel. hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ 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. 02/22/17. 'Artificial Meniscus' Aims to Fill Treatment Gap to Provide Pain Relief Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. 2023 Healthline Media LLC. Limited by United States law to investigational use. 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. Lines and paragraphs break automatically. sU, hD 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 The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. Current state of off the shelf scaffolds and implants for meniscal Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. Before sharing sensitive information, make sure you're on a federal government site. r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov New Knee Surgery Technique: 'Artificial Meniscus' - Healthline 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). You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure.
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