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Boston Scientific Receives FDA Approval for FARAPULSE Pulsed Field Ablation System

DAIC

A company statement reported that its PFA System is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF) and is a unique new alternative to standard-of-care thermal ablation treatment.

Ablation 111
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Boston Scientific Initiates AVANT GUARD Clinical Trial to Evaluate FARAPULSE Pulsed Field Ablation System as First-Line Treatment for Persistent Atrial Fibrillation

DAIC

Patients in the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System, or receive AAD treatment, and followed for three years. The randomized AVANT GUARD trial will enroll more than 500 patients diagnosed with persistent AF at up to 75 sites globally.

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Biosense Webster Announces CE Mark approval in Europe for VARIPULSE Pulsed Field Ablation (PFA) Platform

DAIC

2** Furthermore, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter) was 75.6%. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. Atrial Fibrillation.

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Medtronic Receives FDA Approval of Mapping and Ablation System and Catheter

DAIC

With this approval, Medtronic now offers two PFA technologies available for patients with Afib. tim.hodson Wed, 10/30/2024 - 13:42 Oct. The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients.