Active Implants announced treatment of the final patient in SUN and VENUS trials evaluating the NUsurface® Meniscus Implant for the treatment of persistent knee pain from injured or deteriorated meniscus tissue. The company is pursuing an FDA De Novo 510(k) clearance for the device.
The trials enrolled a combined 243 patients, 176 of which received NUsurface. VENUS (Verification of the Effectiveness of the NUsurface System) commenced in 2015 as a randomized, prospective, controlled study comparing NUsurface to non-surgical care, enrolling 128 patients at 10 U.S. sites. SUN (Safety Using NUsurface) followed in 2016 as a single-arm study assessing the restoration of function similar to a healthy meniscus, enrolling 115 patients at 13 U.S. sites.
If cleared by FDA, NUsurface would be the first “artificial meniscus.” The implant has been used in Europe under CE Mark since 2008 and in Israel since 2011.