Boston Scientific Receives FDA Approval for Expanded Labeling of FARAPULSE™ Pulsed Field Ablation System

Boston Scientific gets expanded PFA label for persistent AFib

Patients whose atrial fibrillation lasts longer than seven days and who do not respond well to drug therapy are now eligible for treatment with the Farapulse pulsed field ablation system.

Boston Scientific gets FDA nod for expanded labeling of Farapulse

Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System

The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation

Boston Scientific Gets FDA Nod for Expanded Labeling of Pulsed Field Ablation System

The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation.

FDA grants expanded labelling approval of Boston Scientific's PFA system

The US FDA has approved Boston Scientific’s expanded instructions for use (IFU) labelling of the Farapulse Pulsed Field Ablation (PFA) System.The post FDA grants expanded labelling approval of Boston Scientific’s PFA system appeared first on Medical Device Network.

FDA Expands Farapulse PFA Approval To Persistent AF After Strong ADVANTAGE AF Trial Results - Data Intelligence

Credit: magicmine | stock.adobe.com Key takeaways The expanded FDA approval of Farapulse introduces a non-thermal ablation option for persistent AF, potentially shifting treatment pathways and protocol design. ADVANTAGE AF data reinforce the importance of operator experience in outcomes, highlighting a growing need for targeted training in emerging PFA technologies. The single-arm trial design and reliance on global site participation offer ins…