CardioFocus announces initiation of HeartLight X3 clinical evaluation


CardioFocus have announced the initiation of a clinical evaluation of the new HeartLight X3 system for the treatment of AF.

Building upon the advanced features of the current HeartLight endoscopic ablation system—direct tissue visualisation, titratable laser energy, and compliant balloon technology—HeartLight X3 is designed to deliver rapid, continuous, 360-degree lesions, potentially making it the ultimate pulmonary vein isolation (PVI) tool for AF. The system offers a new “RAPID mode”. This new mode of operation leverages a precise motor control system that enables uninterrupted, high speed lesion creation.

The initial cases were completed at Na Homolce Hospital in Prague, Czech Republic and performed by Petr Neužil, Head of the department of cardiology, and his team.

“The potential reduction in procedure times combined with a better assurance of gap-free lesion sets will help this device change the way PVI is performed,” said Neužil. “I’m excited to be able to offer this breakthrough approach to my patients during this clinical evaluation phase.”

More than 33 million patients worldwide suffer from AF. AF, the most common type of cardiac rhythm disorder, prevents blood from being pumped efficiently, which can lead to stroke, weakness, breathlessness, fainting, and a significant reduction in quality of life. PVI with the HeartLight X3 System works by using laser energy to create lines of scar tissue to block abnormal electrical pathways that cause AF.

The clinical evaluation of the HeartLight X3 system is planned to continue throughout 2018, with regulatory submissions to occur thereafter.

“CardioFocus is committed to establishing a new benchmark in the field of PVI by delivering leading technologies that provide positive patient outcomes and offer physicians efficient and effective treatment options,” said Burke T. Barrett, chief operating officer at CardioFocus. “We are encouraged by the initial positive feedback we have received on the HeartLight X3 System from Neužil and look forward to expanding this important clinical evaluation to additional European study sites and patients. Compared to our current system, HeartLight X3 holds the potential to accelerate the speed of pulmonary vein isolation threefold. This could lead to extraordinary decreases in procedure time. We are excited to continue to evaluate the system’s performance as part of this clinical evaluation.”

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