CardioFocus published 12-month data from a study of its pulsed field ablation (PFA) system.
ECLIPSE AF, evaluated the safety and performance of the CardioFocus Centauri system with commercial focal ablation catheters. The first-in-human study enrolled 82 patients treated across two centers in Europe. Centauri, which holds CE mark approval, remains investigational in the U.S.
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The open-platform design supports focal contact force catheter workflows. It leverages a custom monopolar waveform designed to achieve transmural lesions while eliminating microbubbles and muscle stimulation. The system enables durable PFA lesions while enhancing procedural efficiency, safety and patient outcomes.
CardioFocus conducted the study of Centauri with the Abbott TactiCath, Boston Scientific IntellaNav StablePoint and Johnson & Johnson ThermoCool SmartTouch ablation catheters.
Results from the ECLIPSE AF trial demonstrated an overall 90.2% 12-month freedom from clinically significant atrial arrhythmia among paroxysmal atrial fibrillation (AF) patients undergoing de novo pulmonary vein isolation (PVI) using three commercial contact-force sensing focal catheters with its Centauri system’s optimized Wave1 PFA waveform.
The study treated patients with paroxysmal and persistent AFib. Subjects demonstrated an overall 80.2% 12-month freedom from clinically significant atrial arrhythmia. The waveform demonstrated an overall chronic PVI durability rate of 89%, per pulmonary vein, in patients treated within the optimized PFA cohorts.
“We are committed to advancing the science of PFA in electrophysiology. We customize our proprietary pulsed electric field waveforms with each catheter system to deliver precise treatments to improve patient outcomes and we are thrilled with the excellent results in the ECLIPSE AF clinical study,” said Steve Ogilvie, Chief Executive Officer at CardioFocus.
CardioFocus also has a next-generation ultra-compliant PFA balloon (OptiShot) under development.
