Sam Brusco, Associate Editor08.08.23
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its POLARx cryoablation system, indicated to treat paroxysmal atrial fibrillation (AFib). The new system features the POLARx FIT cryoablation balloon catheter, which enables 28 and 31 mm balloon sizes in one catheter.
The POLARx catheter can be adjusted and expanded to fit individual anatomy during ablation, which might help mitigate device changeouts. Physicians can also use the device to treat a wider range of pulmonary vein anatomies and create lesions in the best positions to better deliver therapy in heart areas 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," Wilber Su, MD, FHRS, FACC, Director of Electrophysiology, Banner University, told the press. "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 presented at Heart Rhythm 2023 showed safety and effectiveness in treating 385 patients with paroxysmal AFib. The primary event-free rate was 96% at one year with no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas. At one year, 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 clearance in February 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October 2021. The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.
The POLARx catheter can be adjusted and expanded to fit individual anatomy during ablation, which might help mitigate device changeouts. Physicians can also use the device to treat a wider range of pulmonary vein anatomies and create lesions in the best positions to better deliver therapy in heart areas 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," Wilber Su, MD, FHRS, FACC, Director of Electrophysiology, Banner University, told the press. "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 presented at Heart Rhythm 2023 showed safety and effectiveness in treating 385 patients with paroxysmal AFib. The primary event-free rate was 96% at one year with no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas. At one year, 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 clearance in February 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October 2021. The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.