Medical Device Network

Boston Scientific reports outcomes from Farapulse and Farapoint trial

Subjects in the study were monitored using the LUX-Dx insertable cardiac monitor system to detect arrhythmia recurrence.

Boston Scientific has reported positive 12-month primary endpoint outcomes from the ADVANTAGE AF trial’s second phase, assessing the Farapulse pulsed field ablation (PFA) system and Farapoint PFA Catheter as adjunctive treatment for persistent atrial fibrillation (AF).

The single-arm, prospective trial focused on the Farawave PFA Catheter for pulmonary vein isolation (PVI) and posterior wall ablation (PWA), as well as the Farapoint PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL).

Subjects in the study were monitored using the LUX-Dx Insertable Cardiac Monitor (ICM) System to identify any cardiac arrhythmia recurrence and evaluate AF load.

The findings revealed a 73.4% freedom from atrial tachycardia (AT), AFL, surpassing the performance target of 40% or higher.

Additionally, a safety event rate of 2.4% was reported, with no instances of pulmonary vein stenosis, phrenic nerve palsy, or atrio-oesophageal fistula, achieving the performance target of 12% or lower.

Boston Scientific noted that the trial also demonstrated an 81% freedom from symptomatic documented AF recurrence, and 71.6% of subjects showed virtually no atrial arrhythmia (AA) load.

Notably, 52% of subjects had no residual AA events following the blanking period, and 96.4% of those who received treatment with the Farapoint PFA Catheter did not experience AFL recurrence.

The study enrolled 255 subjects across 29 sites in the US, with 141 subjects undergoing CTI ablation with the Farapoint PFA catheter for AFL.

Boston Scientific AF Solutions chief medical officer Brad Sutton said: "These positive study results are an important step forward in the continued innovation of the proven Farapulse PFA system and our broader portfolio of products that treat AF.

"The performance of the devices in this trial – the Farapoint and Farawave PFA catheters, as well as the LUX-Dx ICM system – is an encouraging sign as we work towards expanding our portfolio to provide physicians with an even more robust toolset to treat the growing number of patients with AF."

Farapoint PFA System is expected to receive the FDA approval for expanded use labelling, including persistent AF, as well as European and US regulatory approvals in the second half of this year.

In February, the company received CE markings in the EU for the Farawave NAV Ablation Catheter for paroxysmal AF treatment and its Faraview software.