FDA Approves First Pulsed Field AF Ablation System

18 Dec 2023 • For the first time, the US FDA has approved a pulsed-field ablation (PFA) system for the treatment of of both paroxysmal and persistent atrial fibrillation.

The technology uses microsecond-scale pulsed electrical fields for pulmonary vein isolation (PVI) to reduce AF and is the first PFA system to receive FDA approval for the condition.

Because PFA technology uses a largely nonthermal mechanism of cell death, risk to surrounding tissues is lower than with conventional catheter-based thermal ablation.

The approach has been touted as a means to provide AF ablation in a quicker and safer way, minimizing damage to surrounding structures like the esophagus and phrenic nerve.

Source: FDA | Read full story

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