Endoscopically guided laser catheter receives FDA premarket approval for treating atrial fibrillation

CardioFocus (Marlborough, MA) has received FDA premarket approval (PMA) for its HeartLight endoscopic laser ablation system for treating patients with paroxysmal atrial fibrillation (AF; the most common cardiac arrhythmia). The approved PMA submission contained comprehensive safety and effectiveness data from the company's multi-center HeartLight U.S. Pivotal Clinical Study, a randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the U.S.

Related: FDA accepts CardioFocus' premarket application for endoscopically guided laser catheter

Results from the trial showed that when performing a single ablation procedure using the HeartLight system, the majority of patients experienced freedom from paroxysmal AF at 12 months. In addition, both the primary safety and efficacy endpoints were met.

The HeartLight system allows an electrophysiologist to control the delivery of therapeutic laser energy under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs). The system provides maximum procedural flexibility with a highly compliant balloon that accommodates diverse PV anatomies and laser energy that the clinician delivers under direct endoscopic visualization.

The U.S. pivotal clinical study results are added to dozens of independent studies supporting the HeartLight system. Several published EU single-center studies have reported high rates up to 80% of freedom from AF recurrence measured one year or more after the performance of a single ablation procedure. To date, more than 3400 patients worldwide have been treated using the system.

The company is finalizing preparations to commercialize the system in the U.S.

For more information, please visit www.cardiofocus.com.

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