RESET-AF 3D Study Shows Strong Six-Month Outcomes with BIOTRONIK’s Investigational Pulsed Field Ablation System Data Highlight High Freedom from Recurring Atrial Fibrillation and Excellent Safety Results with ElePulse® PFA System in Patients with Paroxysmal AF

BIOTRONIK today announced the completion of six-month clinical outcomes from the RESET-AF 3D study evaluating the 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. 

RESET-AF 3D is a prospective, multicenter study required for CE marking. It has been designed to evaluate the performance and safety of the ElePulse PFA System. Among more than 100 evaluable patients, more than 90% remained free from recurring AF at six months following treatment. Safety results were equally favorable, 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.¹

“These results are highly encouraging and demonstrate the potential of the ElePulse PFA System to deliver effective pulmonary vein isolation with consistent safety outcomes,” said Dr. Petr Peichl, Principal Investigator and Cardiac Electrophysiology Specialist at the 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. Combining a 3D spiral multi-electrode catheter with a compact PFA generator, the system is intended to enable efficient pulmonary vein isolation while integrating seamlessly into existing electrophysiology workflows. 

“At BIOTRONIK, we see pulsed field ablation as one of the most significant opportunities to advance electrophysiology, and the RESET-AF 3D results further validate the promise of the ElePulse platform,” said Dr. Jörg Pochert, President 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.”

PFA is rapidly reshaping the treatment landscape for atrial fibrillation, making robust clinical evidence critical to advancing innovation in electrophysiology. The RESET-AF 3D findings add to the growing body of evidence supporting the safety, efficacy, and workflow efficiency of next-generation PFA systems for pulmonary vein isolation.

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References

1 Gould, P.A. et al. First-in-human experience from RESET-AF (Rapid onE-Shot Electroporation Trial for Atrial Fibrillation). J Interv Card Electrophysiol (2026). 

About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.