FDA Approves PulseSelect Pulsed Field Ablation System, a Novel Treatment for Atrial Fibrillation

KANSAS CITY, MO – The PulseSelect Pulsed Field Ablation (PFA) system, a new solution for patients with atrial fibrillation (AFib), received FDA approval on December 13, 2023. Dr. Sanjaya Gupta and Dr. Jessica Kline, a cardiologist and electrophysiologist at Saint Luke's Mid America Heart Institute, were the first physicians in Kansas and Missouri to participate in the PULSED AF clinical trial, which was instrumental in securing FDA approval for PFA technology. The PulseSelect PFA system uses PFA – a breakthrough ablation technology that uses pulsed electric fields to effectively, efficiently, and safely treat patients with paroxysmal or persistent AF1.

AFib is a growing heart issue that impacts more than 37 million people worldwide. It is one of the most common cardiac arrhythmias, in which the upper chambers of the heart or atria, quiver or beat very fast and irregularly so the heart cannot effectively pump blood to the rest of the body.

The single-shot PulseSelect PFA system delivers pulsed electric fields through an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that trigger AF. However, unlike traditional methods of ablation that heat (radiofrequency ablation) or cool (cryoablation) the atrial tissue, the PulseSelect PFA system uses a non-thermal approach and preferentially targets heart tissue with the goal of avoiding unwanted injury to surrounding structures, a risk of current ablation technologies.

"The PulseSelect system ushers in a new age of safe, effective, and efficient treatment options for people with AFib," said Dr. Gupta. "We are proud to have been part of this clinical trial, which resulted in the first FDA approval for pulsed field ablation technology. This may prove to be the most significant advance in catheter ablation since the development of radiofrequency ablation more than 30 years ago."

If you or someone you know has AFib, talk to your doctor to see if PFA is a possible treatment option.
Saint Luke’s Mid America Heart Institute will soon be one of only two sites in an eight-state area offering this latest treatment and technology to patients. To learn more visit Saint Luke’s Cardiovascular Consultants.