AtriCure wins FDA nod, posts positive Q1 results

May 11, 2010 by MedCity News

AtriCure, which saw first-quarter sales rise and losses narrow, wins Food & Drug Administration approval to run a clinical trial of a hybrid treatment for atrial fibrillation.

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By Mary Vanac

Cardiac ablation systems maker AtriCure Inc. (NSDQ:ATRC) won a conditional nod from the Food & Drug Administration to evaluate the safety and efficacy of a hybrid procedure to treat patients with persistent forms of atrial fibrillation.

The hybrid procedure “represents a key growth platform” for AtriCure and other companies that seek to serve the atrial fibrillation market, president and CEO David Drachman said in prepared remarks. There is a significant hurdle for potential market players: The FDA has yet to approve cardiac ablation as a treatment for atrial fibrillation.

AtriCure will try a “dual epicardial/endocardial procedure” on 30 patients at up to five U.S. sites, the company said. Enrollment is expected to begin in the second half of the year.

The hybrid procedure combines surgical and catheter ablation with endovascular mapping, using the skills of cardiac surgeons and electrophysiologists to treat patients with persistent atrial fibrillation, an irregular heart rhythm that can lead to heart attack or stroke.

Surgical and catheter ablation techniques often are used separately. Endovascular mapping during procedures — using imaging technology to “see” the effects of ablation procedures in real-time — is just emerging. The trial will use AtriCure’s minimally invasive surgical ablation technology platform and the Biosense Webster ThermoCool catheter ablation technology.