Primary results of the FROZEN-AF IDE trial with the POLARx cryoablation system – Boston Scientific

– Primary results of the FROZEN-AF IDE trial with the POLARx Cryoablation System :
Results from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation System met the safety and effectiveness endpoints of the trial. The study, which examined use of the device for the treatment of patients with paroxysmal, or intermittent atrial fibrillation (AF), included an extension arm for the POLARx FIT Cryoballoon Catheter, a single device capable of enabling 28 and 31mm sizes.

The extension arm sub-study also achieved its safety and effectiveness endpoints and included 50 patients who were treated with at least one application of the 31mm cryoballoon and will be followed for 12 months. At the time of data release, patients had undergone six out of a total of 12 months of follow up. Key findings from the trial : i. The primary safety endpoint of composite acute and chronic primary safety events through 12 months was achieved with an event-free rate of 96.3% at 12 months in the IDE trial and 100% at six months in the extension arm of the study. ii. There were no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas in either patient cohort. iii. The rate of freedom from documented atrial arrhythmias was 79.9% at 12 months in the IDE trial and 88.0% at six months in the extension arm.