FDA OKs Farapulse Pulsed Field Ablation System for Intermittent Afib

The FDA approved the Farapulse pulsed field ablation (PFA) system for paroxysmal atrial fibrillation (Afib or AF), Boston Scientific announced on Wednesday.

The device won an indication for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal Afib. This approval makes Farapulse the second PFA catheter to hit the market.

Just last December, the FDA had approved the first PFA catheter, Medtronic’s PulseSelect, for the treatment of paroxysmal and persistent Afib.

It is generally believed that PFA technology, with its tissue-specific, non-thermal mechanism of cell death — unlike conventional radiofrequency ablation and cryoablation — has the advantage of a reduced risk of unintended esophageal or phrenic nerve injury.

Farapulse’s approval for Afib was based on the ADVENT trial, which showed the technology’s noninferior efficacy and similar safety data at 12 months compared with cryoablation and radiofrequency ablation. Additional real-world data from the large MANIFEST-17K registry supported the safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis, or esophageal injury.

“Within the ADVENT clinical trial, the Farapulse PFA System was shown to be a safe, effective and efficient option for treating paroxysmal AF, and extensive global real-world use has mirrored that profile,” said Vivek Reddy, MD, of Mount Sinai Fuster Heart Hospital in New York City, in the company’s press release.

“Tissue preferentiality and long-term efficacy, combined with markedly shorter procedure times and learning curves, position the Farapulse PFA System with strong potential to become a practice-changing technology for both U.S. physicians and patients alike,” Reddy said.

Boston Scientific said that its ADVANTAGE AF single-arm study is underway, which is looking at the Farapulse PFA system for the treatment of patients with drug-refractory, symptomatic, persistent Afib. Additionally, the AVANT GUARD randomized trial is studying the system versus anti-arrhythmic drug therapy for first-line treatment of persistent Afib.

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