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Procedure is part of U.S.-based clinical trial.
February 3, 2015
By: Chris Delporte
Officials with Active Implants LLC reported first implantation in the United States of the NUsurface meniscus implant, which is designed to treat patients with persistent knee pain due to an injured or deteriorated meniscus. 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, Ohio. The implant is an artificial device designed to relieve knee pain and restore function similar to that of the natural healthy meniscus. The device is implanted by orthopedic surgeons using an arthroscopic approach and a mini-open procedure. The product is approved in Europe under CE regulations and in Israel. Company officials claim that 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 replacement. Active Implants estimates the potential annual worldwide market for the NUsurface product is more than $2 billion. “There aren’t many options for these patients, unfortunately. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery,” said Kaeding. “If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. We’re hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.” The procedure was performed as part of a pivotal trial to demonstrate the superiority of the NUsurface implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. Seven clinical sites in the United States currently are enrolling patients in the study, which is called the VENUS trial (Verification of the Effectiveness of the NUsurface System). “I look forward to the opportunity to offer this exciting new technology to my patients when it is available in the U.S.,” sais Elliott Hershman, M.D., chief medical advisor to Active Implants, as well as chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York and team doctor of the New York Jets football team. “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.” Henry Klyce, chairman and CEO of Active Implants said he was “confident” that the study will demonstrate the superiority of his company’s device compared to the current standard of care. Active Implants LLC is privately held and headquartered in Memphis, Tenn., with additional offices in Driebergen, the Netherlands, and Netanya, Israel.
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