Interim data from Spineart’s Baguera-C investigational device study found the disc, in two-level cases, meets the threshold for a non-inferiority claim against the study control, according to an April 16 news release.
Interim data also yielded the same conclusion for the disc at one level.
The ongoing IDE study is part of Spineart’s path to FDA approval, the release said. The disc is being studied compared to the Mobi-C disc in close to 600 patients.
“The interim analysis data from our 2-level study is a significant milestone for Spineart, coming less than a month after the promising interim results of our 1-level study,” Jerome Trividic, Spineart CEO, said in the release. “These findings bring us closer to providing patients with a highly effective solution for treating symptomatic cervical disease at multiple levels, potentially improving their quality of life.”
