Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (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.

"The new POLARx Cryoablation System, and the expandable cryoballoon catheter specifically, is an exciting development for the effective treatment of AF as it allows physicians to better tailor care for individual patients without sacrificing safety or efficiency," said Wilber Su, MD, FHRS, FACC, Director of Electrophysiology, Banner University. "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."

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 U.S. approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "By prioritizing procedural flexibility and individualized care, this offering transforms a key therapy in the electrophysiology space, addresses the unmet needs of physicians and affirms our commitment to making meaningful innovations to established technologies."

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.