The third and final module needed to get FDA approval to market was submitted, according to an Aug. 8 news release. The last stage will involve an onsite inspection of the clean-room manufacturing facilities.
AxioMed’s device is the first viscoelastic disc replacement to complete a U.S. investigational device exemption clinical study. Five-year data shows no reported failures, no revisions and rare complications. It has been used in Australia, Europe and the Caribbean, the release said.
“We are preparing to begin training surgeons early 2023 in anticipation of FDA approval,” Kingsley Chin, MD, said in the release.
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