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CardioFocus Announces US FDA Approval of HeartLight X3 System for the Treatment of Atrial Fibrillation
May 12, 2020
CardioFocus, Inc. today announced that the U.S. 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. In this pivotal confirmatory study, 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 AFib ablation,” said Vivek Y. Reddy, M.D., Director of Cardiac Electrophysiology and Helmsley Trust Professor of Medicine at The Icahn School of Medicine at Mount Sinai. “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.”
“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,” 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 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 US.”
Written by: CardioFocus
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