CardioFocus has completed enrolment in a trial to evaluate its next-generation HeartLight X3 endoscopic ablation system. According to a press release, a total of 60 patients have been treated in this pivotal confirmatory trial with a one-month follow up. The trial will evaluate time, safety and acute outcomes using the HeartLight X3 system in the treatment of atrial fibrillation as pivotal endpoints.
The press release reports that pulmonary vein isolation with the HeartLight X3 system uses laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause atrial fibrillation. It adds that throughout the trial, the HeartLight X3 system consistently demonstrated short procedure times and achieved very rapid pulmonary vein isolation (in as few as three minutes for a single vein).
Building upon the advanced features of the current HeartLight endoscopic ablation system—direct tissue visualisation, titratable laser energy, and compliant balloon technology—the HeartLight X3 system is designed to deliver quick, continuous, circumferential lesions, potentially making it the ultimate pulmonary vein isolation tool for atrial fibrillation. The system’s RAPID mode is designed to leverage a precise motor control system that enables uninterrupted, high-speed lesion creation under direct control of the physician.
Boris Schmidt (Cardiovascular Center Bethanien, Frankfurt, Germany), an investigator in the trial, says: “With the potential to deliver all ablations in 15 to 20 minutes, the speed and feature set offered by the HeartLight X3 system is unprecedented. The HeartLight X3 System will give us the ability to treat patients more efficiently than ever before.”
Petr Neužil (Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic) comments: “The titratable laser energy, with the convenience of a one-shot approach, give the HeartLight X3 system the potential to be a breakthrough technology in the atrial fibrillation ablation space. Those unique features coupled with the continuous lesions made in RAPID mode and decreased ablation time allow for unprecedented performance.”
Data from the trial are expected to be used to obtain regulatory approvals, with European CE Mark expected in mid-2019.