Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors


FDA approval for the POLARx cryoablation system for the treatment of patients with paroxysmal atrial fibrillation – Boston Scientific

Written by | 18 Aug 2023 | Cardiology

Boston Scientific Corporation announced it has received FDA approval for the POLARx Cryoablation System.The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), features the POLARx FIT Cryoablation Balloon Catheter, a device with the unique capability of enabling two balloon sizes – 28 and 31mm – in one catheter.

Cryoablation is a minimally invasive procedure for treating AF during which a balloon catheter delivers cryotherapy to the pulmonary vein, freezing problematic tissue and creating scarring that blocks irregular electrical signals. 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 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.

Data from the FROZEN-AF IDE clinical trial – a global, prospective, non-randomized, single-arm study presented at Heart Rhythm 2023 – demonstrated the safety and effectiveness of the POLARx Cryoablation System for the treatment of 385 patients with paroxysmal AF. 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. At 12 months, the rate of freedom from documented atrial arrhythmias was 79.9%.

The POLARx Cryoablation System received CE Mark in February of 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October of 2021. The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.


You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.