FDA approves second pulsed field ablation system to treat atrial fibrillation
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Key takeaways:
- The FDA has approved a second pulsed field ablation system for treatment of paroxysmal atrial fibrillation.
- The approval is based on positive findings from the pivotal ADVENT trial and the MANIFEST-17K registry.
The FDA approved a second pulsed field ablation system for the treatment of adults with drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
As an alternative to standard-of-care thermal ablation, approval of the new system (Farapulse) is based on real-world data from the MANIFEST-17K registry, which demonstrated real-world safety of the system for pulmonary vein isolation, as well as the positive results from the pivotal ADVENT clinical trial, according to a press release from Boston Scientific, the manufacturer.
As Healio previously reported, the ADVENT trial demonstrated that pulsed field ablation was noninferior to conventional thermal paroxysmal AF ablation for safety and efficacy, with less pulmonary vein narrowing and faster procedure times.
The system consists of an ablation catheter, an ablation generator and a steerable sheath designed to treat individual patient anatomies using an over-the-wire catheter with variable basket and flower shapes, according to the release.
“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,” Vivek Y. Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and The Mount Sinai Health System, and the Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, said in the 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.”
As Healio previously reported, the first pulsed field ablation system (Pulse Select, Medtronic) was approved in December 2023 for treatment of paroxysmal and persistent AF.
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