FDA Grants CardioFocus’ HeartLight Premarket Approval
The FDA has granted CardioFocus’ HeartLight endoscopic ablation system premarket approval, indicated for treatment of patients with paroxysmal atrial fibrillation.
The approval was based on a pivotal clinical trial that showed a reduction in intermittent AF at 12 months. Further, the system reached both efficacy and safety endpoints.
The system relies on x-ray or mapping support and offers flexibility via a balloon that caters to different pulmonary vein anatomies, and laser energy delivered under direct endoscopic visualization.
HeartLight is now indicated in the U.S. for treating drug refractory recurrent symptomatic paroxysmal AF. — Anisa Jibrell