Written submissions may be made to the contact person on or before April 4, 2023. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. ^>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? FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. 02/22/17. The medial meniscus replacement mimics the . 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. All rights reserved. The product is approved in Europe under CE regulations and in Israel. . Lines and paragraphs break automatically. 787 0 obj <>stream It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.[i]. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. Our website services, content, and products are for informational purposes only. 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. 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 device is approved in Europe under CE regulations and in Israel. 2022 Active Implants. 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. Surgery is usually only necessary for severe. 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. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . The other is expected to be completed in 2023. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. 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. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. 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. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. 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 .gov means its official.Federal government websites often end in .gov or .mil. 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. Can Manufacturing Technology Enhance Healthcare? Download : Download high-res image (115KB) 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. Learn about when you might need ankle replacement surgery, how the procedure is done, and what you can expect from this surgery. 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. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 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. 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. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. There arent many options for these patients, unfortunately. " [It] is designed for patients with persistent knee pain following medial 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. Press Releases | Active Implants | Orthopedic Implant Solutions Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. TEAMS (captions):teams.microsoft.com/meetup. 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. +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " The procedure was performed as part of a pivotal trial to demonstrate the superiority of the NUsurface Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. 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. Last Meniscus Implant Treated in Clinical Trial - Active Implants Learn all about hip resurfacing, including the procedure, what to expect during recovery, and how it compares with hip replacement surgery. 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. 03/16/17. 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. The .gov means its official.Federal government websites often end in .gov or .mil. Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in Time allotted for each presentation may be limited. app. So, for us, it is very exciting to finally bring the device to people in Israel.. Every knee has two menisci crescent-shaped discs of cartilage (soft tissue) that connect the thigh bone to the shinbone. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. If you require accommodations due to a disability, please contact Artair.Mallett@fda.hhs.gov or 301-796-9638 at least 7 days in advance of the meeting. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. 11.1 Panel Non -Voting Questions . As a result of its unique materials and composite structure and design, it 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. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. sU, 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. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. The implant is made from a medical-grade plastic. As I wrote in . 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. x{_w X& G 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. FDA is committed to the orderly conduct of its advisory committee meetings. Copyright 2023 The Ohio State University Wexner Medical Center. For more information, visit www.activeimplants.com. 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. 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 . MD+DI Online is part of the Informa Markets Division of Informa PLC. People who have the surgery typically can go home soon after the operation. Informa Markets, a trading division of Informa PLC. Active Implants LLC, a developer of orthopedic implant solutions for joint preservation, said its NUsurface Meniscus Implant has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. 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. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. NUsurface is designed to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. After this procedure, patients no longer need prolonged protected weight bearing or braces. A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. 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.. 3 Things You Should Know Before Having Knee - Active Implants Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. 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). '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. Active Implants partners with Geistlich Pharma for NUsurface We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. 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. FDA Grants Breakthrough Designation to 'Artificial Meniscus 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. Active Implants Appoints Ted Davis President and Chief Executive Officer. 0W9.&WDEj8tH $$o| AJ-AB]O.!*q!EkdyNM?pw4[\|4cwmxuP%b9q;z? 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. 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. Before sharing sensitive information, make sure you're on a federal government site. 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. r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. The site is secure. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. Meniscal substitution, a developing and long-awaited demand Number 8860726. 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. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. His pain started following that partial meniscectomy. 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. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down and select the appropriate advisory committee meeting link. All rights reserved. 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. The next day he started physiotherapy to gain full range of movement.. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. 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. "cC*RS Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. Study design: Cohort study; Level of evidence, 2. Active Implants is privately held with headquarters in Memphis, Tennessee. Right now, Arbel says the only treatment for people who have a painful or degraded meniscus has been pain medications, physiotherapy, and intra-articular injections (directly into the joint) to relieve pain. The NUsurface Implant was invented and developed in our R&D center in Israel. 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. The site is secure. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Investors are cautioned that actual events or results may differ from Active Implants expectations. The new procedure is a lot simpler than other options. The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. 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. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. Active Implants Enters Partnership with Geistlich Pharma AG for 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 NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. 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. 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. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. Quest to Reach Another Segment in Liquid Biopsy with New M&A, MedCon 2023 Session Highlights MDUFA V, TAP Pilot, EU MDR, The Expanding Value of Medical Devices in a Digital World, Allowed HTML tags:

. 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. 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. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. Receiving an IDE is a significant milestone towards obtaining Pre-Market Approval in the U.S., Elliott Hershman, M.D. The meeting will be open to the public. 2022 Active Implants. Two clinical trials are scheduled in the United States right now. FDA Breakthrough Device Designation Given To Active Implants For FDA NON-Voting Questions . These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDAs website at the time of the advisory committee meeting, and the background material will be posted on FDAs website after the 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). h24U0P6A A NUsurface implant doesnt burn any bridges, Arbel said. Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. Exclusion Criteria: NUsurface Implant Registry - Full Text View - ClinicalTrials.gov An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. 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 currently marketed in Belgium, Germany, Italy, and Israel. The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the 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. 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. 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. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for . 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 artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. The Breakthrough Device Designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, said Ted Davis, president and CEO of Active Implants. 2). The agency has been rapidly accepting devices into this pathway this year. 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. Biomaterials for meniscus and cartilage in knee surgery: state of the 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. Get tips from Ohio State experts right to your inbox. The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. Arbel is optimistic about the effectiveness of the new implant. Contact us today for more information about the NUsurface Meniscus Implant. September 20, 2019 By Sean Whooley. 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. endstream endobj 790 0 obj <>stream 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. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.