CardioFocus submits HeartLight X3 PMA application to FDA

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

CardioFocus has submitted a pre-market approval (PMA) supplement to the US Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of atrial fibrillation (AF). This supplement follows the original, approved PMA of the HeartLight Endoscopic System. US commercial launch of the HeartLight X3 System will immediately follow approval of the PMA supplement, the company said.

The HeartLight X3 System is a next-generation AF ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System. The system performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Using direct tissue visualisation, titratable laser energy and compliant balloon technology, the HeartLight X3 System offers a unique RAPID mode, CardioFocus said in a press release. RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician, resulting in significantly reduced procedure times.

During the pivotal confirmatory study of 60 patients, the HeartLight X3 System achieved very rapid PVI, in as few as three minutes for a single vein.

“The excitement surrounding the introduction of HeartLight X3 into the European market has been palpable,” said Burke T Barrett, chief executive officer at CardioFocus. “We have treated nearly 500 patients with the technology and the ability to deploy rapid, continuous laser energy circumferentially and outside of the pulmonary vein is compelling. The submission of this PMA supplement marks a tremendous milestone as we prepare to bring this breakthrough product to the US. Based on our initial interactions with FDA, we anticipate launching HeartLight X3 into the US market this year.”


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