AtriCure Inc. (NSDQ:ATRC) shares took a hit this morning after the FDA raised some questions about its Synergy device.
Ahead of its date with the watchdog agency’s circulatory system devices panel tomorrow, AtriCure shares dropped 17 percent to $9.65 in afternoon trading yesterday from an opening price of $11.61, after the FDA raised questions about the clinical data used to support its bid for pre-market approval.
Shares crept back up to close at $10.16 at the end of the day, but were down another 2 percent to $9.98 in mid-morning trading today.
AtriCure’s Synergy cardiac ablation system uses either heat or cold to create precise scar tissue in the heart to correct arrhythmia, or irregular heart rhythms.
The FDA documents released ahead of the panel hearing raised concerns about changes in the type of patients enrolled in AtriCure’s clinical studies. AtriCure’s original study was to have included only patients with permanent atrial fibrillation, according to the documents, but the company won agency approval to include patients with longstanding persistent AF and paroxysmal AF.
The panel noted that the FDA approved AtriCure’s final patient population, but wondered whether follow-up procedures were appropriate for patients with slightly different conditions.
AtriCure’s studies also found that primary safety and effectiveness endpoints weren’t met for non-paroxysmal patients alone, although both were satisfied for the total population of patients.