Boston Scientific’s POLARx Cryoablation System Receives the US FDA’s Approval for Paroxysmal Atrial Fibrillation
Shots:
- The US FDA has approved the POLARx cryoablation system indicated to treat paroxysmal atrial fibrillation (AFib). It features the POLARx FIT cryoablation balloon catheter, which enables 28 and 31-mm balloon sizes in one catheter
- The approval was based on (FROZEN-AF IDE) trial results that demonstrated the safety and effectiveness of the POLARx Cryoablation System, event-free rate of 96.0% at 12mos. with no reports of mod. or sev. pulmonary vein stenosis, persistent phrenic nerve palsy, or esophageal fistulas, the rate of freedom from documented atrial arrhythmias was 79.9%. The results were presented at Heart Rhythm 2023
- The POLARx FIT catheter received approval in the EU, Japan, Canada & other Asia Pacific markets in 2023
Ref: PR Newswire | Image: Boston Scientific
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
