Top experts at Boston Scientific, Medtronic and Acutus Medical shared insights about pulsed-field ablation’s potential at DeviceTalks Boston.Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation is treated.
PFA’s roots go back to the dc ablation tech of the 1980s. These days, PFA generally involves high-voltage electric pulses from a catheter-delivered electrode or electrodes, delivered each at a tiny fraction of a second. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury resistant.
It’s hard these days to find a cardiac device company that is not doing something related to PFA. At our DeviceTalks Boston conference and expo in May 2022, we were lucky enough to have a panel of executives from three of the leaders in the space:
- Dr. Kenneth Stein is SVP and CMO of CRM at Boston Scientific. The company acquired the rest of Farapulse in 2021. The Farapulse PFA treated nearly 2,000 patients in nine European countries last year. It has a CE Mark, and Boston Scientific is seeking FDA clearance.
- Dr. Khaldoun Tarakji is the CMO of the Cardiac Ablation Solutions operating unit at Medtronic. The medtech giant is in the process of completing a global clinical trial of its PulseSelect PFA system. It’s conducting the study in the U.S. under an FDA investigational device exemption. Medtronic also announced in January that it plans to acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. The plan is for the deal to close in the coming months.
- Dr. Steven Mickelsen founded Farapulse and is presently the chief translational science officer at Acutus Medical. The Acutus PFA system is under investigation in CE Mark countries.