US-based healthcare technology Medtronic has announced positive results for its PulseSelect Pulsed Field Ablation (PFA) System from a clinical study, dubbed PULSED AF.

PULSED AF is the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial of the PulseSelect PFA System.

In the IDE study, PulseSelect PFA System surpassed its safety performance goal, showing one of the lowest adverse event rates of 0.7%.

PULSED AF showed at least 80% superiority in efficacy performance goal, along with clinical success, and freedom from recurrence of any symptomatic atrial arrhythmias for each cohort.

Medtronic cardiac ablation solutions business president Rebecca Seidel said: “Today’s findings demonstrate a critical achievement in the decade-long commitment we have made to researching PFA and underscore our confidence in the PulseSelect System.

“We are taking the same comprehensive approach to PFA that we took with the introduction of the single-shot Arctic Front Advance cryoballoon, and that involves building a deep, extensive body of clinical evidence and strong collaboration with clinicians globally.

“The single-shot PulseSelect System, together with the focal Affera Sphere-9 mapping and ablation catheter, will allow us to offer a complementary suite of PFA technologies to help treat patients with AF and other arrhythmias.”

According to Medtronic, PULSED AF is the first and only multi-centre IDE clinical study to evaluate the safety and effectiveness of PFA technology for AF ablation.

PFA is a breakthrough ablation technology that leverages pulsed electric fields to effectively isolate the pulmonary veins for the treatment of patients with paroxysmal or persistent AF.

The prospective, single-arm, multi-centre IDE clinical trial has enrolled 300 patients, across 41 sites in nine countries, including the US, Canada, Europe, Australia, and Japan.

The single-shot PulseSelect System is designed to deliver pulsed electric fields through an ablation catheter to interrupt irregular electrical pathways that trigger AF.

PulseSelect System is indicated for the treatment of AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF.

Unlike traditional ablation methods, such as radiofrequency ablation or cryoablation, the PulseSelect System uses a non-thermal approach, said Medtronic.

PULSED AF study principal investigator (PI) Atul Verma said: “Uniquely, these results represent the first prospective, global, large-scale study with two different, rigorously monitored patient populations that demonstrates an impressively low adverse event rate of 0.7%.

“The results of PFA trials have been highly anticipated among the EP community to help us treat the growing number of AF patients around the world.

“The high rate of 80% or more in clinical success and the promising safety and efficiency results from PULSED AF will help establish PFA as an exciting new option for patients.”