CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system.
Marlborough, Mass.-based CardioFocus’ 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 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 a news release.
The study met all endpoints, with overall procedure times clocking at 73.7 minutes for HeartLight X3, compared to 206 minutes from the historical control study for the original device. Long-term data found that 71.9% of patients treated with HeartLight X3 achieved chronic study success, compared to 61.1% of patients in the historical control HeartLight study.
“FDA approval of the HeartLight X3 system represents a substantial milestone for CardioFocus and is a promising new treatment option for the millions of Americans suffering from paroxysmal AFib,” CardioFocus CEO Burke Barrett said in the release. “By pairing the most compliant and dynamic balloon technology with the ability to deploy titratable laser energy at unprecedented speed while using direct visualization, we are able to offer a completely unique ablation technology to cardiac electrophysiologists. With this approval in hand, we will initiate a focused rollout of HeartLight X3 across the U.S.”
Dr. Vivek Reddy, director of cardiac electrophysiology at the Icahn School of Medicine at Mount Sinai, described the HeartLight X3 system as ideal for AFib ablation because of its speed, control and predictability. “This is a transformational technology when it comes to AFib ablation. Introducing direct visualization of the pulmonary veins and combining it with the ability to create continuous lesions is compelling.”