On Oct. 26, the FDA’s Circulatory System Devices Panel will review the Cincinnati-area device maker’s Premarket Approval Application (PMA) for its Synergy ablation system, according to a statement from West Chester, Ohio-based AtriCure.
The review marks yet another step in a process that could end up with AtriCure becoming the first company to obtain a label for the surgical treatment of atrial fibrillation (AF), which would be a huge milestone and value driver for the company and its shareholders.
The 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.
It’s important to note that AtriCure’s Synergy ablation system is already on the market; the company is now simply seeking the AF label for the device, which would give the company the right to market it for the treatment of AF.
AtriCure studied the ablation device in treating AF patients in a clinical trial called ABLATE that it initiated in 2007. The trials investigated the use of AtriCure’s ablation device on AF patients who were already undergoing other surgical heart procedures, typically valve replacements or bypasses, Piton said.
“An AF label would allow us to educate and train the medical community about this procedure and increase its adoption for the AF patient pool already undergoing surgical procedures,” Piton said.