CardioFocus has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its HeartLight endoscopic ablation system to treat patients with drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF).
The approval was based on the US pivotal and randomized controlled study, in which the primary safety and efficacy endpoints have been met.
The trial included 353 participants, which were randomized at 19 arrhythmia centers across the US.
HeartLight system enables electrophysiologist to control the delivery of therapeutic laser energy, in addition to electrically and durably isolate the pulmonary veins (PVs).
Featuring advanced catheter ablation technology, the HeartLight system integrates an endoscope to offer physicians with the capacity to see within the heart.
The company said the HeartLight system is designed to offer the clinician maximum procedural flexibility with a balloon that accommodates diverse PV anatomies and laser energy that the clinician delivers under direct endoscopic visualization.
CardioFocus regulatory and clinical affairs vice president Burke Barrett said: "The achievement of the HeartLight system PMA approval is a major milestone and the result of dedicated teamwork among our employees, the clinical sites and study participants, and we are grateful for this remarkable support.
"It is also important to highlight the efficiency and professionalism of the FDA, reflected in this PMA review from filing to approval in eight months."
The company also reported that it is finalizing preparations to commercialize the HeartLight system in the US.