Atricure’s PMA approval for Atrial Fibrillation indication under scrutiny this week

Atricure (NASDAQ:ATRC) share price was hit on Monday after a  U.S. Food and Drug Administration(FDA) report expressed “concerns” about a clinical trial for one of the company’s ablation devices.

FDA published a report in advance of  its advisory panel meeting this Wednesday to review AtriCure’s application for approval of an atrial fibrillation(AF) indication for the company’s Synergy ablation system, which is already approved under 510(k) for ablation of cardiac tissue.

The purpose of this Pre-Market Approval (PMA) is to expand the indications for use to include the specific claim of treatment of persistent or longstanding persistent AF in the concomitant surgery setting, which would if successful make Atricure the only company that’s obtained an AF label for a surgical device.

Interestingly the report states that; “Although not approved in the US for treatment of atrial fibrillation, its widespread use for that purpose is evident in the literature.”

Of interest on the European side of the pond, the AtriCure Synergy Ablation System first received the CE Mark in March 2007 for ablation of soft tissue, with CE Mark approval updated for the treatment of cardiac arrhythmias including atrial fibrillation in February 2008.

Returning to the report, FDA noted “several concerns” with clinical trial data in Atricure’s PMA for the AF indication.

FDA’s stated opinion is that 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.

However when considering the least healthy patients, the trial meets neither its safety nor effectiveness goals, the report said.

AtriCure’s share price fell 13 percent to $10.16 with heavy trading volume on the day, nearly quadruple AtriCure’s three-month average.

The report goes on to state that; “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 without trying to second guess the outcome, it’s far from certain that the “concerns” noted in the report will convince the panel to advise against approval of AtriCure’s application, whatever the sentiment expressed in share trading yesterday.

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 indication by the middle of next year.

Source: FDA,