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# FDA OKs Boston Scientific Cryoablation Device
- URL: https://www.fdaweb.com/fda-oks-boston-scientific-cryoablation-device/
- Published: 2023-08-08T12:00:00.000Z
- Updated: 2026-09-14T18:48:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155052

FDA has approved a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation (AF). The device features the POLARx FIT Cryoablation Balloon Catheter, which allows two balloon sizes – 28mm and 31mm – in one catheter. “The system addresses known limitations by reimagining existing cryoablation offerings, allowing physicians to adjust and expand the new POLARx FIT catheter to fit a patient’s individual anatomy during an ablation procedure, which can help mitigate time-consuming and disruptive device changeouts,” the company says. “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 AF originate.”

Approval was based on data from the FROZEN-AF IDE clinical trial that demonstrated the safety and effectiveness of the device in 385 patients with paroxysmal AF, the company says. In the trial, the “primary event-free rate, or freedom from procedure- or device-related events, was 96.0% at 12 months, with no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas,” it says. At 12 months, the rate of freedom from documented atrial arrhythmias was 79.9%, it adds.