Boston Scientific has announced the achievement of primary efficacy and safety endpoints in the ADVENT Study of the FARAPULSE Pulsed Field Ablation (PFA) System.
FARAPULSE is a nonthermal treatment, which selectively applies electric fields for ablating heart tissue in patients with atrial fibrillation (AF).
The pivotal, randomised clinical study compared the efficacy and safety of the system versus standard-of-care ablation, either cryoablation or radiofrequency, to treat patients with paroxysmal, or intermittent, AF.
Over the course of 12 months, the data indicated that the system was as effective as standard-of-care treatments, even though most physicians had only worked with thermal ablation in the past.
The prospective, multicentre trial included 607 US patients with paroxysmal AF who had earlier been unsuccessfully treated with a minimum of one anti-arrhythmic drug.
Boston Scientific global chief medical officer and senior vice-president Kenneth Stein said: “These data underscore the superior procedural efficiency of this novel technology, and real-world use continues to yield strong safety and efficacy outcomes.
“The performance of the FARAPULSE PFA System in this trial is an encouraging sign of the potential utilisation of the device in the US and we look forward to further studying the system for the treatment of patients with persistent AF in the ADVANTAGE AF clinical trial, which began enrolment earlier this year.”
In 2021, the company received CE Mark for the FARAPULSE PFA System. So far, it has been used to treat over 25,000 patients across the globe.