FDA approves cryoablation system for paroxysmal AF with expandable balloon catheter
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Key takeaways:
- A cryoablation system for the treatment of paroxysmal atrial fibrillation gained FDA approval.
- The system features a cryoablation balloon catheter that expands to 28 mm and 31 mm.
Boston Scientific announced it received FDA approval for its cryoablation system indicated for the treatment of patients with paroxysmal atrial fibrillation.
The system (POLARx) features an expandable cryoablation balloon catheter (POLARx FIT) designed to enable 28-mm and 31-mm balloon sizes, according to a company press release.
The approval is based on the results of the prospective, nonrandomized, single-arm FROZEN-AF Investigational Device Exemption clinical trial that demonstrated the safety and effectiveness of the cryoablation system in 385 patients with paroxysmal AF. Freedom from procedure- or device-related events was 96% and freedom from atrial arrhythmias was 79.9% at 12 months. According to the release, there were no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas.
"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 at Banner University, said in the release. "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."
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