CardioFocus HeartLight X3
The HeartLight Excalibur Balloon used with the HeartLight X3 system. [Image courtesy of CardioFocus]
The system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA supplement with the FDA so that it could launch HeartLight X3 in the U.S.
Approval for the device follows a 60-patient study that revealed rapid pulmonary vein isolation (PVI) from the HeartLight X3, with PVI performed in as much as three minutes for one single pulmonary vein, according to the company.
