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# Farapulse Ablation System Given Breakthrough Status
- URL: https://www.fdaweb.com/farapulse-ablation-system-given-breakthrough-status/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144075

FDA has granted Farapulse a breakthrough device designation for its Farapulse Pulsed Field Ablation System and its use in treating drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation. The device uses non-thermal energy to create durable lesions to improve the safety profile of cardiac ablation. It is intended to offer an alternative to current thermalcardiac ablation procedures without risk of thermal damage caused by radiofrequency and cryo-ablation, the company says.