New FARAWAVE™ NAV Ablation Catheter and FARAVIEW™ Software combine with OPAL HDx™ Mapping System to provide visualization during pulsed field ablation MARLBOROUGH, Mass., Oct. 18, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and…
Tag: Farapulse
Boston Scientific Receives FDA Approval for FARAPULSE™ Pulsed Field Ablation System
MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary […]
ADVENT Study of the FARAPULSE™ Pulsed Field Ablation System Meets Primary Efficacy and Safety Endpoints
MARLBOROUGH, Mass. and AMSTERDAM, Aug. 27, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE™ Pulsed Field Ablation (PFA) System*, a nonthermal treatment in which electric fields selectively ablate heart tissue in […]
Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies
Additional real-world outcomes further demonstrate safety, efficacy and procedural reproducibility of the FARAPULSE™ Pulsed Field Ablation System* Results from global trial of the POLARx™ Cryoablation System* meet safety and effectiveness endpoints MARLBOROUGH, Mass., May 20, 2023 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) […]
Boston Scientific Exercises Option to Acquire Farapulse, Inc
Acquisition complements company’s electrophysiology portfolio to include the only commercially available cardiac pulsed field ablation technology MARLBOROUGH, Mass., June 24, 2021 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it exercised its option to acquire the remaining shares of Farapulse, Inc. The acquisition […]
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’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 […]
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. […]
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 […]