First Pulsed-Field Ablation System Gets FDA Approval

For the first time, the US Food and Drug Administration has approved a pulsed-field ablation (PFA) system for the treatment of atrial fibrillation (AF): the PulseSelect PFA system.

Device maker Medtronic announced the news Thursday, noting that the system is indicated for the treatment of both paroxysmal and persistent AF.

Like other PFA systems, PulseSelect achieves pulmonary vein isolation not through thermal ablation, like radiofrequency and cryoballoon ablation, but through electroporation—it delivers short, high-power electrical pulses to punch holes in the cell membranes of the cardiomyocytes. 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.

The FDA’s approval, which follows a similar decision in Europe last month, was supported by the findings of PULSED AF, a single-arm, pivotal, investigational device exemption (IDE) trial. Use of the PulseSelect system was associated with a 0.7% rate of serious procedure- and device-related adverse events, well below the 13% prespecified performance goal.

The primary efficacy endpoint was freedom from a composite of acute procedural failure, arrhythmia recurrence, repeat ablation, direct current cardioversion, left atrial surgery, or antiarrhythmic drug escalation through 1 year, with rates of 66.2% and 55.1%, respectively, in the paroxysmal and persistent AF cohorts. Those rates exceeded the performance goals of 50% and 40%, respectively.

Commercialization of the PulseSelect PFA system is set to begin in early 2024, Medtronic said.

Other PFA systems are in development, including the Farapulse system (Boston Scientific), which performed well against thermal ablation in the pivotal ADVENT trial reported at the European Society of Cardiology Congress 2023 in August. Though not yet approved by the FDA, it has received CE Mark approval in Europe.