First-Of-Its-Kind Expandable Cryoballoon Catheter Advances Cryoablation Therapy

Boston Scientific (Marlborough, MA, USA) has secured U.S. Food and Drug Administration (FDA) approval for its POLARx Cryoablation System. This state-of-the-art system, intended for treating patients with paroxysmal AF, incorporates the unique POLARx FIT Cryoablation Balloon Catheter. This innovative device enables two balloon sizes of 28 and 31mm within a single catheter. The system allows physicians to adjust the POLARx FIT catheter to match a patient's specific anatomy during the ablation process, reducing the need for time-consuming and disruptive device changeouts.

In addition, the device allows for the treatment of a wider range of pulmonary vein anatomies and creates lesions at the most effective spots, ensuring that therapy targets the specific heart regions generating disruptive signals that cause AF. A global, prospective, non-randomized, single-arm study has confirmed the safety and efficiency of the POLARx Cryoablation System in treating 385 paroxysmal AF patients. The primary success rate, indicating the absence of any procedure- or device-related complications, stood at an impressive 96.0% at the 12-month mark. Notably, there were no cases of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas. After 12 months, 79.9% of the participants remained free from documented atrial arrhythmias.

"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."

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