HeartLight X3 Endoscopic Ablation System gets European approval

HeartLight X3 Endoscopic Ablation System has received European CE Mark approval for ablation treatment for atrial fibrillation. This Rapid and Accurate Cardiac Ablation procedure has been cleared in Europe.

More than 33 million patients worldwide suffer from AFib, the most common type of cardiac rhythm disorder. In Europe alone, it is estimated that the number of patients will rise to 14-17 million by 2030.

HeartLight X3 Endoscopic Ablation System is a third generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, which 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 visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 System's unique RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under the direct control of the physician resulting in consistently reduced procedure times.

"Our clinical results using the HeartLight X3 System have been outstanding, with unprecedented treatment speed and precise lesion creation," said Boris Schmidt, MD an investigator in the pivotal confirmatory trial at Cardioangiologisches Centrum Bethanien in Frankfurt, Germany. "Based on our experience with the device, we feel confident that the HeartLight X3 System is poised to change the way AFib ablation is performed in Europe."

In the pivotal confirmatory evaluation of 60 patients, the HeartLight X3 System consistently achieved very rapid PVI, in as few as three minutes for a single vein. The trial also found that the System has the potential to complete all required ablations in less than 20 minutes.

Ablation of cardiac tissue is one of the most common ways of treating atrial fibrillation. Interventional cardiologists have to work quite a bit to make sure the energy they’re delivering hits the correct areas. The HeartLight X3 System from CardioFocus is designed to make this process much faster and it has just been approved in the EU.

Cardiac ablations generally involve performing pulmonary vein isolations, which can take over an hour to perform. By using the HeartLight X3, physicians are able to isolate individual veins within three minutes and perform all required ablations of a procedure within twenty minutes. The whole procedure from start to finish can be done within an hour.

As with previous HeartLight systems, physicians are able to see the anatomy they’re working with, can control the amount of laser energy delivered, and benefit from a compliant balloon that makes sure everything is anchored in place.