ACTIVE IMPLANTS WRAPS UP NUSURFACE TRIAL ENROLLMENT (Orthopedics This Week)
Memphis, Tennessee-based Active Implants LLC has announced that the final patient has been treated in the two clinical trials evaluating its NUsurface Meniscus Implant for the treatment of persistent knee pain caused by injured or deteriorated meniscus tissue.
The trials are being conducted as part of the process to obtain U.S. Food and Drug Administration (FDA) De Novo 510(k) clearance. If approved, says the company, the NUsurface Implant would be the first “artificial meniscus.”
“We are now one step closer to filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement, which is a large unmet need in the orthopedic market,” said Ted Davis, president and CEO of Active Implants.
“With enrollment complete, we will continue to work closely with the FDA and now focus our efforts on collecting the data required for the U.S. regulatory submission. We thank our investigator surgeons and patients for making this day possible.”
According to the company, the two clinical trials enrolled a combined 243 patients, 176 of which received the NUsurface Meniscus Implant.
The VENUS (Verification of the Effectiveness of the NUsurface System) trial is a randomized, multi-centered, prospective, controlled study comparing the NUsurface Meniscus Implant to the non-surgical standard of care and enrolled 128 patients at 10 U.S. study sites.
The SUN (Safety Using NUsurface) trial is a single-arm study assessing the safety and probable benefit of the NUsurface Meniscus Implant in restoring function similar to that of a natural, healthy meniscus and enrolled 115 patients at 13 U.S. study sites. Active Implants conducted the two different types of studies concurrently in order to bring the NUsurface Meniscus Implant to market as quickly as possible while the company worked with the FDA to finalize the regulatory clearance for marketing in the U.S.
Elliott Hershman, M.D., orthopedic surgeon at Lenox Hill Hospital in New York City and medical director for the studies told OTW, “The most exciting part has been the opportunity to create a new treatment for a clinical problem that has up until now been a difficult situation to manage for both doctors and patients.”
Ted Davis, president and CEO of Active Implants, commented to OTW, “With enrollment complete, we will continue to work closely with the FDA and now focus our efforts on collecting the data required for the U.S. regulatory submission.”