After this procedure, patients no longer need prolonged protected weight bearing or braces. According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. hD The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Active Implants partners with Geistlich Pharma for NUsurface DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. FDA is committed to the orderly conduct of its advisory committee meetings. Recent breakthrough device designations include a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, aninteratrial shunt for heart failure from V-Wave, B. Braun'sdrug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronaryintravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze,and two cancer diagnostic tests. 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). Most people can begin to walk normally in about 3 months, he added. 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. %PDF-1.6 % The site is secure. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. However, that number is expected to skyrocket to 3.5 million cases by 2030, an increase of nearly 400%. A trial 15 to 20 years ago attempted to prevent cartilage degeneration after part of the patients menisci was removed. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. 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. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. 02/22/17. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. FDA NON-Voting Questions Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. 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. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. This polyurethane-carbonate implant mimics the biomechanical function of the medial meniscus by protecting the cartilage from overload, Arbel told Healthline. 3 ). Exclusion Criteria: 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. J Bone Joint Surg Am. But, we need a longer follow-up to verify it.. 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. NUsurface - Rimoni Industries 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. 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. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. FDA NON-Voting Questions . 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. 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. 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. AC joint surgery is used to treat injuries to the AC joint between your shoulder blade and collarbone. The new procedure is a lot simpler than other options. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. No other technologies today can be compared with the function of the NUsurface Implant, Arbel said. 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 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. AGENCY: Food and Drug Administration, HHS. Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed . The product is approved in Europe under CE regulations and in Israel. CAUTION Therefore, you should always check the Agencys website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. . 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. FDA Grants Breakthrough Device Designation for NUsurface Implant The meeting will be open to the public. 03/16/17. 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. Methods: There were 65 patients in the implant group (30 randomized) and 35 in the control group. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 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 . 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. ^>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? The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. Previous Post First NUsurface Meniscus Implant - Active Implants The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. The NUsurface Implant was invented and developed in our R&D center in Israel. 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. Written submissions may be made to the contact person on or before April 4, 2023. Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Active Implants wins breakthrough nod for NUsurface knee implant FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. New Medical Device May Eliminate Need for Some Knee Replacement Surgery, Meet Mako, the Robot Helping Doctors Perform Error-Free Surgeries, Knee Surgery That Reduces Pain But Doesnt Heal the Injury, Steroid Injections in the Knee and Hip Can Cause More Damage Than Previously Realized, Comparing Your Options for Carpometacarpal Arthroplasty, What to Expect from Ankle Replacement Surgery, Types of Surgery to Repair Joints: Arthroplasty and More, Your Guide to Hip Resurfacing Arthroplasty, Your Guide to Total and Partial Elbow Arthroplasty. "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 device is currently marketed in Belgium, Germany, Italy, and Israel. 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. Copyright 2023. Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. h[n7OYEI 0Mf Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews A new report published in the journal Radiology found corticosteroid injections may be more damaging for the joint than previously thought. However, it could still be years before this procedure is available in the United States. 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 SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. 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. endstream endobj 789 0 obj <>stream The artificial meniscus device is already available inEurope and, if cleared by FDA, would also be the first artificial meniscus in the United States. x{_w X& G r~v,v,c,;. v,t,, U.S. FOOD DRUG - fda.gov 5214, Silver Spring, MD 20993-0002, Akinola.Awojope@fda.hhs.gov, 301-636-0512, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Active Implants estimates the potential annual worldwide market for the NUsurface product is over $2 Billion. 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. 05/01/17. Two clinical trials are scheduled in the United States right now. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. 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. h24U0P6A For more information, visit www.activeimplants.com. 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. The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. The products listed here include some of the newest medical technology available. Active Implants is privately held with headquarters in Memphis, Tennessee. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. Agar said in a press release that many people who get meniscal repairs later experience pain. Current state of off the shelf scaffolds and implants for meniscal For press inquiries, please contact the Office of Media Affairs at mailto:fdaoma@fda.hhs.gov or 301-796-4540. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. Investigational device. An estimated 750,000 such procedures are performed each year. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. There haven't been many options for these patients, unfortunately. If approved, the implant could be used for people who would otherwise need a partial or total knee replacement. 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. 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 approved, it will be the first artificial meniscus in the United States. 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. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. The artificial meniscus is made from medical-grade polymer and other unique materials. Advanced Orthopedics & Sports Medicine Specialists Performs First. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. 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 Grants Breakthrough Designation to 'Artificial Meniscus 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. 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 initial surgery took place during an FDA-approved trial of the NUsurface Meniscus comparing it to the current standard of care for patients with persistent knee pain following meniscus 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 function in the medial compartment of a knee in which the medial meniscus has been resected. 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.. As I wrote in . Web page addresses and e-mail addresses turn into links automatically. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. There is no need for any fixation with sutures, screws, glue, or other stuff. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. The device is approved in Europe under CE regulations and in Israel. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. 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 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). Please comment on the benefit-risk profile for use of the NUsurface Meniscus Implant in 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. No need to drill into or cut the bone. hU[O@+!d&DE5. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. 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. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. So, we think that it will prevent or delay the need for total knee replacement, he said. FDA has granted Active Implants'NUsurface meniscus implant a breakthrough device designation. Number 8860726. The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, American Academy of Orthopedic Surgeons Annua, Society for Arthroscopy and Joint Surgery / G, 6060 Primacy Parkway Suite 460 Memphis, TN 38119. 6060 Primacy Parkway Suite 460 Memphis, TN 38119901.762.0352Privacy Policy EU Website: www.activeimplants.eu, Knee Replacement Options and Meniscus Pain Relief, American Academy of Orthopedic Surgeons Annua, Society for Arthroscopy and Joint Surgery / G, 6060 Primacy Parkway Suite 460 Memphis, TN 38119, The Ohio State University Wexner Medical Center, https://clinicaltrials.gov/show/NCT02108496. Informa Markets, a trading division of Informa PLC. Download : Download high-res image (115KB) Learn about when you might need ankle replacement surgery, how the procedure is done, and what you can expect from this surgery. I look forward to the opportunity to offer this exciting new technology to my patients when it is available in the U.S., stated Elliott Hershman, M.D., Chief Medical Advisor to Active Implants. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the hUKo0+:nPK ]Mk5F ?IpF4'nS$&LkA`S}5b*KnupO&uxgG@ The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. Investors are cautioned that actual events or results may differ from Active Implants expectations. 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.. His pain started following that partial meniscectomy. The general function of the committee is to provide advice and recommendations to the Agency on FDAs regulatory issues. Time allotted for each presentation may be limited. The device is a polymeric disc-shaped device implanted in the medial compartment of 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. endstream endobj 791 0 obj <>stream April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement, An official website of the United States government, : 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. 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.