Biotronik today announced the completion of six-month clinical outcomes from the RESET-AF 3D study evaluating its investigational ElePulse pulsed field ablation (PFA) system in patients with symptomatic paroxysmal atrial fibrillation (AF). The results demonstrated “strong efficacy and an excellent safety profile”, according to the company.
RESET-AF 3D is a prospective, multicentre study required for CE marking, and it has been designed to evaluate the performance and safety of the ElePulse PFA system. Among more than 100 evaluable patients, over 90% remained free from recurring AF at six months following treatment. Safety results were equally favourable, with no device-related serious adverse events and a procedure-related serious adverse event rate of less than 2%. The RESET-AF 3D study builds on positive findings from the earlier RESET-AF first-in-human experience.
“These results are highly encouraging and demonstrate the potential of the ElePulse PFA system to deliver effective pulmonary vein isolation [PVI] with consistent safety outcomes,” said principal investigator Petr Peichl (Institute for Clinical and Experimental Medicine [IKEM], Prague, Czech Republic). “The high rate of freedom from recurring AF together with the significant improvements in patient-reported quality of life underscore the promise of this technology as we continue its clinical evaluation.”
The ElePulse PFA system is designed to simplify AF ablation through a true single-shot, single-position approach, Biotronik states. Combining a 3D spiral multi-electrode catheter with a compact PFA generator, the system is intended to enable efficient PVI while integrating “seamlessly” into existing electrophysiology workflows, the company adds.
“At Biotronik, we see PFA as one of the most significant opportunities to advance electrophysiology, and the RESET-AF 3D results further validate the promise of the ElePulse platform,” commented Jörg Pochert, president of growth businesses at Biotronik. “As electrophysiologists increasingly seek safe, effective and efficient ablation technologies, ElePulse is designed to advance procedural simplicity while delivering strong clinical outcomes.”
