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FDA Greenlights Boston Scientific's Cutting-Edge POLARx™ Cryoablation System

Wednesday, August 09, 2023

Boston Scientific Corporation has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its latest innovation, the POLARx™ Cryoablation System. This advanced system is designed to treat patients with paroxysmal atrial fibrillation (AF) and introduces the POLARx FIT Cryoablation Balloon Catheter, a remarkable device capable of accommodating two balloon sizes – 28 and 31mm – within a single catheter.

Cryoablation, a minimally invasive procedure used to address AF, involves using a balloon catheter to apply cryotherapy to the pulmonary vein, effectively freezing problematic tissue and creating scarring that disrupts irregular electrical signals. What sets the POLARx system apart is its innovative approach to overcoming existing limitations in cryoablation technology. The POLARx FIT catheter can be adjusted and expanded during an ablation procedure, allowing physicians to tailor the treatment to each patient's unique anatomy. This adaptability not only streamlines the procedure by eliminating time-consuming device changes but also expands the range of treatable pulmonary vein anatomies. By strategically creating lesions in optimal positions, the system enhances the delivery of therapy to the areas of the heart where AF-causing signals originate.

The POLARx Cryoablation System, particularly its versatile cryoballoon catheter, represents a significant advancement in AF treatment. It empowers physicians to personalize treatment plans for individual patients without compromising safety or efficiency. The FDA's approval of the POLARx Cryoablation System, already having been utilized for over 25,000 patients globally, signifies a substantial leap forward in treating AF and heralds a new era of cryoablation capabilities. This innovative approach, centered around procedural flexibility and patient-centric care, transforms the landscape of electrophysiology.



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