U.S. Food and Drug Administration staffers issued a (pdf) report in advance of an FDA advisory panel’s Wednesday meeting to review AtriCure’s application for approval of an atrial fibrillation label for the company’s already-approved Synergy ablation system.
The report noted “several concerns” with clinical trial data in Cincinnati-area Atricure’s Premarket Approval Application (PMA) for the AF label.
The trial “appears to have succeeded” if all enrolled patients are considered, but it included a handful of healthier patients, which biased the study toward success in terms of safety, according to the report.
When considering the least healthy patients, the trial meets neither its safety nor effectiveness goals, the report said. And that’s likely what spooked investors.
On a day in which both the Dow and Nasdaq were up, AtriCure’s stock fell 13 percent to $10.16. Volume was heavy on the day, nearly quadruple AtriCure’s three-month average.
Still, nervous investors should remember the following sentence from the report: “When examining the primary safety and effectiveness results for all subjects enrolled in [the trial], which includes subjects with paroxysmal AF, the trial appears to have succeeded.”
So it shouldn’t be a foregone conclusion that the “concerns” noted in the report will convince the panel to advise against approval of AtriCure’s application.
The FDA panel is expected to make a nonbinding recommendation on the same day of the review. The panel’s recommendation then goes to the FDA itself, which is expected to make the final decision on the AF label by the middle of next year, AtriCure CFO Julie Piton said last month.
Receiving the AF label would be a significant milestone for AtriCure and would make it the only company that’s obtained an AF label for a surgical device.