Boston Scientific announces FDA approval of the POLARx Cryoablation System

Boston Scientific announced it has received U.S. FDA approval for the POLARx Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation, 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.