Biomaterials for meniscus and cartilage in knee surgery: state of the Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. 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.. The new procedure is a lot simpler than other options. Our website services, content, and products are for informational purposes only. This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. If approved, it will be the first artificial meniscus in the United States. Arbel is optimistic about the effectiveness of the new implant. [It] is designed for patients with persistent knee pain following medial meniscus surgery. Two surgeons at two medical centers in Israel performed the surgery last month with the NUsurface Meniscus Implant device. FDA Breakthrough Device Designation Given To Active Implants For You can find additional information at the links below: Sign up to receive email updates on Recent Device Approvals. 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 implant is made from a medical-grade plastic. `A#X/hC > ]IUVil E6uVmwpYzGYUijK/,?j/^*,.Yg[]O#\uoYy_m*[k+l-:_$LPH[xE9!]1}*! The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. endstream endobj 789 0 obj <>stream The 1st Artificial Meniscus has earned the FDA's - OrthoStreams 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. They can wean themselves off crutches when theyre comfortable and progress to normal activities when tolerable. The implant is made from polycarbonate-urethane (PCU) - a medical grade plastic. Actifit recently received Food & Drugs Administration (FDA) approval for clinical use and is available for medial and lateral meniscus repair. The NUsurfaceImplant is intended to mimicthe function of the natural meniscus and redistributeloads transmitted across the knee joint. 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. 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. For more information, visit www.activeimplants.com. Final approval by the FDA is expected this year. FDA NON-Voting Questions Surgeons say the Calypso device can help relieve pain for people with osteoarthritis in their inner knee region. Download : Download high-res image (115KB) NUsurface Implant Registry - Full Text View - ClinicalTrials.gov The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint . Biomechanical studies of the device show that the pressure distribution on the cartilage after implantation is the same as on a normal meniscus. 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 . Earlier this year Active Implants gained some attention from Needham & Co.'s Mike Matson, who included the company on a list of interesting private medtech companies. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Active Implants LLC Secures First Tranche of a $40 Million Equity Financing. Ron Arbel, MD, of Ramat-Aviv Medical Center, treated the first commercial surgery on November 12 in a private clinic. As a result of its unique materials and composite structure and design, it does not require fixation to bone or soft tissues. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. CAUTION There is no need for any fixation with sutures, screws, glue, or other stuff. 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. [i] Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. Johns Hopkins Medicine researchers found that a common surgery known as arthroscopic partial meniscectomy accounted for an estimated two-thirds of all orthopedic knee arthroscopy procedures in older patients in 2016 and that this surgery may not even be that effective. The 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. Patient Population: . "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. h243Q0Pw/+Q0L)64 )Ic0i 2022 Active Implants. Recently-Approved Devices | FDA Active Implants is privately held with headquarters in Memphis, Tennessee. Before sharing sensitive information, make sure you're on a federal government site. 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 does not assume any obligation to publicly update or revise any forward-looking statements for any reason. 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. Subscribe. 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. 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. The NUsurface Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. So, we think that it will prevent or delay the need for total knee replacement, he said. This robotic assistant has helped with more than 300,000 operations in over 600 hundred hospitals and is transforming the way doctors perform joint. Most people can begin to walk normally in about 3 months, he added. 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. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. So, for us, it is very exciting to finally bring the device to people in Israel.. Two clinical trials are currently ongoing in the USA, with FDA approval for the NUsurface Meniscus Implant still pending [ 97 ]. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The NUsurfacemeniscus implant is designed for patientswith persistent knee pain following medial meniscus surgery. 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 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. Current state of off the shelf scaffolds and implants for meniscal 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. 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:

. 2023 Healthline Media LLC. Ohio State was the first in the United States to implant the NUsurface Meniscus Implant as part of an FDA-approved clinical trial. These conditions, which affect quality of life, can eventually lead to the need for knee replacement surgery. 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. People who have the surgery typically can go home soon after the operation. All rights reserved. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. [KhPg[T+n>%?cwyw_Oy,u]e>>dvm ' See additional information. Artificial Meniscus Earns FDA Breakthrough Status | 2019-10-01 - FDAnews Oral presentations from the public will be scheduled on April 20, 2023, between approximately 1 p.m. and 2 p.m. Eastern Time. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. 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. Preliminary Results From a US Clinical Trial of a Novel - PubMed The device is a polymeric disc-shaped device implanted in the medial compartment of The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. NUsurface - Rimoni Industries +'%F[jjY#g= k$a9i \ 4 hpk.JItq8N " A NUsurface implant doesnt burn any bridges, Arbel said. The FDA granted Active Implants breakthrough designation for its NUsurface Meniscus Implant, an artificial meniscus that has already been cleared for marketing in Europe. 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. 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). Contact us today for more information about the NUsurface Meniscus Implant. 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. 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. All rights reserved. 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. 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. 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 procedure begins with routine arthroscopic preparation of the meniscus, followed by implantation of the plastic meniscus through a small incision. 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. 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.

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