The Latest Cardiac and Vascular News
First phase of ADVANTAGE AF clinical trial achieves safety and effectiveness endpoints for treatment of drug-resistant, symptomatic, persistent atrial fibrillation with the FARAPULSE™ Pulsed Field Ablation System Sub-analysis from OPTION clinical trial highlights consistent safety and…
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…
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 veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., […]
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 patients with atrial fibrillation (AF). The study is the first […]
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) today announced data supporting use of the company’s key electrophysiology […]
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 will complement the existing Boston Scientific electrophysiology portfolio to include […]
– 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 […]
– 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 […]
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 […]
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 […]
