FDA Approves a Second Pulsed-Field Ablation System

US physicians now have access to a second pulsed-field ablation (PFA) option to treat their patients with atrial fibrillation (AF) following the US Food and Drug Administration’s approval of the Farapulse system, device maker Boston Scientific announced Wednesday.

According to the company, the product is indicated for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal AF. Of note, the first PFA system approved by the FDA—the PulseSelect system (Medtronic)—has an indication for both paroxysmal and persistent AF.

Boston Scientific said it plans to launch its Farapulse system in the US immediately.

PFA differs from conventional thermal ablation modalities in that it works by delivering high-power electrical pulses that puncture the cell membranes of cardiomyocytes. This electroporation approach is believed to be safer than radiofrequency or cryoballoon ablation because it is more specific for myocardial tissue, thus limiting damage to surrounding structures like the esophagus and phrenic nerve.

Approval of the Farapulse system was supported by data from the pivotal ADVENT trial, the first randomized study to pit a PFA technology against thermal ablation. The results showed that the Farapulse system provided noninferior safety and efficacy through 1 year, with shorter total procedural and ablation times (though longer fluoroscopy times).

The FDA also considered supportive real-world data on more than 17,000 patients included in the MANIFEST-17K registry. That study showed a low overall rate of major complications with the Farapulse system, with no cases of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury and only rare instances of potentially serious complications like coronary spasm and hemolysis-related acute renal failure requiring hemodialysis.

The Farapulse system, which includes the Farawave ablation catheter, the Farastar ablation generator, and the Faradrive steerable sheath, received a breakthrough device designation from the FDA in 2019 and CE Mark approval in Europe in 2021.

Additional data will be forthcoming from the ADVANTAGE AF trial, which is testing the Farapulse system in patients with drug-refractory, symptomatic, persistent AF and will also evaluate use of the Farapoint PFA catheter for cavotricuspid isthmus ablation to treat atrial flutter. In addition, the ongoing AVANT GUARD trial is evaluating PFA as a first-line treatment for persistent AF versus anti-arrhythmic drugs.