Boston Scientific’s Polarx Cryoablation System Receives FDA Approval

August 8, 2023—Boston Scientific Corporation announced it has received FDA approval for the Polarx cryoablation system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AFib).

According to the company, the system features the Polarx Fit cryoablation balloon catheter, which enables two balloon sizes, 28 and 31 mm. Physicians can adjust and expand the catheter to fit a patient’s individual anatomy during an ablation procedure. The device also allows physicians to treat a wider range of pulmonary vein anatomies and create lesions in optimal positions to better deliver therapy to areas of the heart where disruptive signals that cause AFib originate.

Boston Scientific advised that the safety and effectiveness of the Polarx cryoablation system was demonstrated in the FROZEN-AF investigational device exemption clinical trial. The global, prospective, nonrandomized, single-arm study was composed of 385 patients with paroxysmal AFib.

In the FROZEN-AF trial, the primary event-free rate (freedom from procedure- or device-related events) was 96% at 12 months, with no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas. At 12 months, the rate of freedom from documented atrial arrhythmias was 79.9%. The data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society held May 19-21 in New Orleans, Louisiana.

“The new Polarx cryoablation system, and the expandable cryoballoon catheter specifically, is an exciting development for the effective treatment of AFib as it allows physicians to better tailor care for individual patients without sacrificing safety or efficiency,” commented Wilber Su, MD, in Boston Scientific’s press release. “As we saw in clinical evaluation, the combination of maneuverability and variable balloon sizes makes this system particularly useful in addressing longstanding challenges with varying cardiac anatomies and brings to the table occlusion capabilities physicians aren’t used to seeing with traditional systems.” Dr. Su is director of electrophysiology at Banner University in Phoenix, Arizona.

The Polarx cryoablation system received European CE Mark in February 2020 and Japanese Pharmaceuticals and Medical Devices Agency approval in October 2021. The Polarx Fit catheter received approval in Europe, Canada, Japan, and other Asia Pacific markets in 2023, advised Boston Scientific.