FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals / Research and Development

FDA Accepts CardioFocus’ PMA Application for Endoscopic Ablation System

Sept. 16, 2015

The FDA has accepted for review CardioFocus’ PMA application for its HeartLight Endoscopic Ablation System, which treats atrial fibrillation.

The accepted application includes safety and effectiveness data from a clinical trial by the company, which included 353 patients being treated at 19 arrhythmia centers across the U.S.

Research of the trial published in the Journal of the American College of Cardiology found that HeartLight ablation “was non-inferior to standard irrigated [RF ablation] in terms of the primary efficacy and safety endpoints.”

The results are still considered to be preliminary, as the FDA has not reviewed the study. — Michael Cipriano