nusurface meniscus implant fda approval

The Companys main focus, in partnership with sports medicine surgeons, is developing and clinically evaluating the NUsurface Meniscus Implant for patients with knee pain. If you 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. The NUsurface Meniscus Implantis a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. What Is the Effectiveness of Acromioclavicular (AC) Joint Surgery. 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. 03/16/17. 11.1 Panel Non -Voting Questions . . FDA intends to make background material available to the public no later than 2 business days before the meeting. An outpatient procedure could provide patients relief from the pain of knee osteoarthritis without the need for medications. Surgeons at two medical centers in Israel have completed successful implantations of the NUsurface Meniscus Implant, manufactured by Active Implants LLC. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. 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. But, we need a longer follow-up to verify it.. There arent many options for these patients, unfortunately. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. The two surgeons who performed the procedures have been involved with the NUsurface Implant development since 2006. People who experience persistent knee pain even after surgery may soon be able to benefit from a revolutionary solution the worlds first artificial meniscus. 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. "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. According to Active Implants, more than 2 million partial meniscectomys are performed worldwide annually in an attempt to alleviate pain. Get tips from Ohio State experts right to your inbox. Healthline Media does not provide medical advice, diagnosis, or treatment. The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . 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. MEMPHIS, Tenn.(BUSINESS WIRE)Active Implants LLC today announced the first implantation in the United States of the NUsurface Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or deteriorated meniscus. We are confident that with this study we will demonstrate for superiority of the NUsurface Meniscus Implant over standard-of-care treatments.. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. (T)fu;$@%PXGZy,/y bB>d0{axN6?%:~%d4}^$}d}_D*-)?%edRx,@0ud@#xgYB{'B`J!F0CxJ0:*iCQ}.cb1qIG%: 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.. Peter Verdonk, M.D., PhD, an investigator in the Multi-Center trial from Orthopaedic Center Monica Hospitals Antwerp and University of Ghent, Belgium, said, I am impressed with the results observed to date and believe this technology could represent a new method of treating patients with meniscus problems who are often on a long and painful progression to knee replacement.. The NUsurface meniscus implant is an investigational treatment for patients in the United States with persistent knee pain following medical meniscus surgery. 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. request for the NUsurface Meniscus Implant sponsored by Active Implants, Inc. Limited by United States law to investigational use. Investors are cautioned that actual events or results may differ from Active Implants expectations. If approved, it will be the first artificial meniscus in the United States. Exclusion Criteria: Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. Copyright 2023 The Ohio State University Wexner Medical Center. It also prevents further degeneration of the cartilage that happens when part of the meniscus is removed after a tear, or in case of a nonfunctioning, degraded meniscus.. 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. Learn all about total and partial elbow arthroplasty, the difference between linked and unlinked replacements, and what to expect during recovery. 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. x{_w X& G 2022 Active Implants. The site is secure. 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. 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. The Companys main focus is to develop and clinically evaluate the NUsurface Meniscus Implant for patients with knee pain. Gabriel Agar, MD, of Shamir Medical Center, completed the first commercial surgery on November 11 in a public hospital. Progressively, the implant will form a customized fit to the patients knee contour. 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 site is secure. '3H,Y-0U}^}na9L Hz({CN{^cZ]T9fV@E4|~)iVS6 m>apt. endstream endobj 788 0 obj <>stream A NUsurface implant doesnt burn any bridges, Arbel said. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. The artificial meniscus doesnt require fixation to bone or soft tissues, according to the manufacturer. 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. "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. The implant is made from polycarbonate-urethane (PCU) a medical grade plastic. You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. 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 Investigational device. 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. 2023 Healthline Media LLC. 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. 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. 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:

. The artificial medial meniscus implant NUsurface meniscus implant (Active Implants, USA) is a non-anchored femur conforming implant, which is designed to sit within the medial compartment, between . 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. The FDA 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. About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to help relieve knee pain and restore function similar to that of the healthy meniscus. sU, 2022 Active Implants. h243Q0Pw/+Q0L)64 )Ic0i 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). [+92:y7*:2)ic 5Q8VXa%- D$( u480 @lY/h"l`v G{*[yEY ZhIU#F|;@72s## @Fia( $shP?!M=;,U>- }CpPJ2/bvX|lq+0G5MZ :P@D-PC6]O]N=N{:,=59uiFr@4h`z. Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 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 . Active Implants Appoints Ted Davis President and Chief Executive Officer. The NUsurface implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Surgery is usually only necessary for severe. Ill start to do more and more implantations for people who have had partial medial meniscectomies and who suffer from pain, he said. There haven't been many options for these patients, unfortunately. ^>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? 787 0 obj <>stream If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. 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. 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. 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 . Arbel is encouraged by the results of studies of the new artificial meniscus. He then began to experience degeneration of his cartilage, which Arbel said always happens after a partial meniscectomy. hD . The NUsurface Implant is currently marketed in Belgium, Germany, Italy and Israel. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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.. 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. DATES: The meeting will take place virtually on April 20, 2023, from 9 a.m. to 6 p.m. Eastern Time. 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. So, for us, it is very exciting to finally bring the device to people in Israel.. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' 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. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. The NUsurface artificial meniscus (from Active Implants, Memphis, TN) is the first implant of its kind that is FDA approved for the US. 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. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. 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. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. About the NUsurface Meniscus Implant: The NUsurface Meniscus Implant is an artificial device designed to help relieve knee pain and restore function similar to that of the healthy meniscus. Currently, an estimated 720,000 patients undergo knee replacement surgery yearly. The potential worldwide market for the NUsurface is estimated at more than $2 Billion annually. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. The medial meniscus replacement mimics the . The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market, Davis said. Arbel is optimistic about the effectiveness of the new implant. If you require accommodations due to a disability, please contact Artair.Mallett@fda.hhs.gov or 301-796-9638 at least 7 days in advance of the meeting. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason. You insert it into the knee through a small 5 to 6 centimeter [1.96 to 2.36 inch] aperture. Study design: Cohort study; Level of evidence, 2. Most people can begin to walk normally in about 3 months, he added. The NUsurface Meniscus Implant is the first "artificial meniscus" to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the . Q#(Gd!c!QGzHCN0$ 0M@-`Xj7[ Bn@UrM9>9hr$V_ -PYD Download : Download high-res image (115KB) The procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. They act as shock absorbers and stabilize the knee. h24U0P6A 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. Copyright 2023. 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). MD+DI Online is part of the Informa Markets Division of Informa PLC. The surgeon inserted a metal spacer in the medial compartment of the knee, but it failed, he said. This program is designed to ensure patients and healthcare providers have more timely access to vital devices. app. Active Implants Receives FDA Breakthrough Device Designation for NUsurface Meniscus Implant, Designation Allows Expedited Review of First Artificial Meniscus. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. 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. FDA is committed to the orderly conduct of its advisory committee meetings. 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. Patient Population: . endstream endobj 792 0 obj <>stream 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105, 2022 Active Implants. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. %PDF-1.6 % 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. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! Agar said in a press release that many people who get meniscal repairs later experience pain. 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. "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.". Time allotted for each presentation may be limited. We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. AGENCY: Food and Drug Administration, HHS. Web page addresses and e-mail addresses turn into links automatically. The NUsurface Meniscus Implant (pictured right) is made by Active Implants LLC, the technology leader in cushion-bearing orthopaedics. 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 NUsurface Meniscus Implant is an investigational treatment 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. Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The .gov means its official.Federal government websites often end in .gov or .mil. An estimated 750,000 such procedures are performed each year. The NUsurface Implant has been CE-approved for commercialization in the European Union and Israel. 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. Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. 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. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. Contact us today for more information about the NUsurface Meniscus Implant. J Bone Joint Surg Am. endstream endobj 791 0 obj <>stream European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. hU[O@+!d&DE5. CMC arthroplasty can involve a tendon transfer, a total joint replacement, a suture, or temporary wire. The U.S. Food and Drug Administration (FDA) recently granted the NUsurface Implant a breakthrough device designation. is the Chief Medical Advisor of Active Implants and is the Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York. Dr. Hershman said, The NUsurface Meniscus Implant is a novel, composite polymer implant, which is used to treat knee patients who have pain and disability arising from osteoarthritis caused by a previous meniscectomy, meniscus dysfunction or insufficiency. The next day he started physiotherapy to gain full range of movement.. People who have the surgery typically can go home soon after the operation. The new procedure is a lot simpler than other options. Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. Please log on 20 minutes before the webcast to test your signal. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. Device Approvals, Denials and Clearances, Recalls, Market Withdrawals and Safety Alerts. endstream endobj 790 0 obj <>stream [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. FDA is committed to the orderly conduct of its advisory committee meetings. h[n7OYEI 0Mf Often, that residual pain is caused by cartilage degeneration from aging or osteoarthritis. [It] is designed for patients with persistent knee pain following medial meniscus surgery. " [It] is designed for patients with persistent knee pain following medial 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. 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. The product is approved in Europe under CE regulations and in Israel. 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. All rights reserved. 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 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. If you have a disability and experience difficulty accessing this content, contact our webmaster at webmaster@osumc.edu. Advanced Orthopedics & Sports Medicine Specialists Performs First. 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). 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. Boston Childrens Hospital reports there are more than 500,000 meniscal tears in the United States every year. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. 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 device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. You may have to refresh your browser before logging on. All rights reserved. Meniscus Replacements in Colorado with NUsurface Meniscus Implant. 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 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. Before sharing sensitive information, make sure you're on a federal government site. 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). TEAMS (captions):teams.microsoft.com/meetup. Were hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery..

Schrader Funeral Home Obituaries Ballwin, Mo, Nga Gymnastics Level Requirements, Grafton Base Hospital Visiting Hours, Maureen Downey Hartman Obituary, Spiritual Abuse Conference, Articles N