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.
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