CardioFocus said today that it’s launching a clinical trial for the latest iteration of its HeartLight direct-visualization ablation device for treating atrial fibrillation.
A company representative told MassDevice.com that the 60-patient study of the HeartLight X3, the next generation of the HeartLight Excalibur balloon that won CE Mark approval in the European Union last September. The first cases in the study were performed by Dr. Petr Neužil of Prague’s Na Homolce Hospital.
HeartLight X3 is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The first HeartLight version won pre-market approval from the FDA in April 2016.
“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,” Neužil said in prepared remarks. “I’m excited to be able to offer this breakthrough approach to my patients during this clinical evaluation phase.”
“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,” added COO Burke Barrett. “We are encouraged by the initial positive feedback we have received on the HeartLight X3 System from Prof. 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.”