Michael Bodner: Pulsed field ablation is an exciting new frontier in the treatment of atrial fibrillation (AFib). Biosense Webster is testing our PFA technology in the US and the EU using the Varipulse multielectrode circular catheter designed to isolate the pulmonary veins along with the Trupulse generator which is specifically designed to be used with the Carto mapping system and our PFA catheters.

In Europe, we have the inspIRE clinical study to evaluate the safety and effectiveness of our Varipulse PFA catheter and Trupulse generator in order to obtain the CE Mark. What we learned from that study helped shape the admIRE study, which is the US PMA study for Varipulse and Trupulse which began enrollment in April 2022. (Also see "J&J, Acutus And Boston Scientific Announce Plans For Pulsed Field AF-Ablation Technologies" - Medtech Insight, 5 October, 2020.)

For the last few decades, radiofrequency (RF) ablation has been the standard of care, and we have been leaders in this field. There are still more chapters to come with RF, even as PFA is developing.

For example, Biosense Webster will soon launch the QDot Micro catheter, which is the latest generation RF catheter that features microelectrodes and enables high power short duration ablation at up to 90 watts for four seconds. PFA is a different mechanism for creating an ablation, and the promise of pulsed field ablation is extremely exciting for many reasons.

One is that it may have a better safety profile than RF ablation without sacrificing long-term effectiveness. Of course, this will need to be proven in the clinical studies. With inspIRE and admIRE, we are learning a lot about pulsed field ablation, and they’re the start of our journey into PFA. But there’s more PFA solutions in development which we are very excited about.

Exec Chat: Biosense Webster Is Ready For Next Chapters Of The Electrophysiology Story

More from Cardiology

More from Device Area