Tag: Farapulse

FARAPULSE Receives European Approval To Commercialize Its Leading Pulsed Field Ablation System To Treat Paroxysmal Atrial Fibrillation

– FARAPULSE becomes first company in the world to commercialize a cardiac PFA system – MENLO PARK, Calif., Jan. 29, 2021 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced that it has received the Conformité Européene (CE) Mark for its FARAPULSE Pulsed Field Ablation (PFA) system for the treatment of […]

FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval

– Large, Randomized Controlled ADVENT Trial Designed to Establish New Gold Standard for AF Ablation – MENLO PARK, Calif., Dec. 17, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT […]

FARAPULSE’s Pioneering Clinical Results Link Compelling Long-term Outcomes to Established Safety and Lesion Durability Data

MENLO PARK, CA, May 7, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) and its pulsed field ablation (PFA) technology for Atrial Fibrillation featured heavily in the collection of science published online by the Heart Rhythm Society in lieu of an annual meeting. Highlights of the data presented by the investigators from seven […]

FARAPULSE Receives FDA Breakthrough Designation for its Endocardial Pulsed Field Ablation System

MENLO PARK, CA, May 8, 2019 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the “Company”) today announced it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its Endocardial Ablation System. The system is being developed to advance the […]