Florida hospital system implements new cryoablation therapy for AFib

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In August 2023, the U.S. Food and Drug Administration (FDA) approved the POLARx Cryoablation System for the treatment of patients who have paroxysmal atrial fibrillation (AFib). Developed by Boston Scientific Corporation, the new system includes a device that has the unique capability of enabling two balloon sizes (28 and 31 mm) in one catheter. 

Florida-based BayCare Health System participated in research trials of the system and equipment. Kevin Makati, MD, who served as principal investor throughout the trials, performed the first procedure following FDA approval. Dr. Makati is an interventional cardiologist at BayCare’s St. Joseph’s Hospital Heart and Vascular Institute in Tampa. 

According to Boston Scientific’s press release at the time of approval, the novel technology addresses limitations in AFib treatment by “reimagining 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.”

In addition, the cryoablation system provides additional tools to treat a range of pulmonary vein anatomies and create lesions in optimal positions to deliver therapy more effectively to areas of the heart where disruptive signals that cause AFib 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 at Banner University in Phoenix. “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.”

Results from the FROZEN-AF IDE clinical trial—a global, prospective, non-randomized, single-arm study—demonstrated the system’s efficacy and safety for the treatment of 385 patients with paroxysmal AFib. At 12 months, the primary event-free rate was 96%, with no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas. The rate of freedom from documented atrial arrhythmias was 80% at 12 months.

As of now, three of BayCare’s 16 locations are using the specialized catheter in its ablation procedures for the treatment of AFib. Additionally, the POLARCryoablation System has been used to treat more than 25,000 patients worldwide.

“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,” said Nick Spadea-Anello, president, electrophysiology, at Boston Scientific.

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