Data on the first five patients enrolled in a study involving Ablation Frontiers' new radio frequency (RF) ablation catheter and generator were presented by Stefania Riva, MD, at the 7th annual session of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) on April 3 in Milan, Italy.
The patients, two of whom presented with permanent atrial fibrillation (AF) and three with paroxysmal AF, underwent successful pulmonary vein isolation without any reported complications, Ablation Frontiers said. Procedure times averaged 32 minutes and after three months median follow-up, four of five patients were in sinus rhythm, according to researchers.
The researchers conducted the procedures using the pulmonary vein ablation catheter (PVAC) and multi-channel GENius generator for ablation catheters, according to the Carlsbad, Calif.-based company.
The PVAC was used for both mapping and ablating during the procedures. “The use of a single mapping and ablation catheter has streamlined and simplified the procedure," said Riva, one of the study’s authors.
“We are very much encouraged by these interim results and sincerely thank Paolo Della Bella, MD, chief of the arrhythmology department at the University of Milan's Institute of Cardiology and one of the authors along with his colleagues for their outstanding work in this study and their dedication to finding a cure for AF," said Keegan Harper, CEO of Ablation Frontiers. “These preliminary data show the promise of the Ablation Frontiers technology for patients with either permanent or paroxysmal atrial fibrillation. This early report aligns well with anecdotal data from other clinics in Europe. We are very pleased with the resonance this new device is finding in the clinical community.”