US FDA approval granted for HeartLight X3 endoscopic ablation system

The HeartLight Excalibur Balloon used with the HeartLight X3 system
The HeartLight Excalibur Balloon used with the HeartLight X3 system

CardioFocus has announced that the US Food and Drug Administration (FDA) has approved the next-generation HeartLight X3 endoscopic ablation system for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF).

Approval of the HeartLight X3 system came as a result of a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients, CardioFocus said in a press release. In this pivotal confirmatory study, the company said, the X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single pulmonary vein.

“The HeartLight X3 System introduces a new level of speed, control and predictability for physicians – making it an ideal tool for AF ablation,” said Vivek Y Reddy, director of Cardiac Electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai (New York, USA). “This is a transformational technology when it comes to AF ablation. Introducing direct visualisation of the pulmonary veins and combining it with the ability to create continuous lesions is compelling.”

“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 AF,” said Burke T Barrett, chief executive officer at CardioFocus. “By pairing the most compliant and dynamic balloon technology with the ability to deploy titratable laser energy at unprecedented speed while using direct visualisation, 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 USA.”


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