Field Medical Starts First-in-Human Pulsed-Field Ablation Trial

Field Medical initiated a first-in-human study of its FieldForce pulsed field ablation (PFA) system.
 
The company began the Ventricular Catheter Ablation Study (VCAS) at the Na Homolce Hospital in Prague, Czech Republic. The VCAS trial will enroll up to 60 patients at up to five sites across the globe.
 
The Cardiff-by-the-Sea, Calif.-based company hopes to address the issues with current PFA and radiofrequency (RF) ablation systems, which includes more predictable, time efficient, and safe options. Field Medical’s PFA technology is the first, only contact force PFA catheter optimized to work in the heart’s ventricle.
 
Field Medical founder and CEO Steven Mickelson, MD was also the founder of PFA company Farapulse, which was acquired by Boston Scientific in 2021. The company is challenging both Boston Scientific and Medtronic, who both have U.S. Food and Drug Administration (FDA)-cleared PFA technologies.
 
The FieldForce PFA system includes the company’s FieldBending technology, which uses non-intuitive physics to deliver brief, intense electric fields that were engineered to safely and dramatically reduce procedure times. Mount Sinai Health System’s director of electrophysiology Vivek Reddy, MD said FieldForce is already showing significant promise early in trials.
 
“This is my first experience with a technology capable of achieving rapid complete transmural left ventricular (LV) ablation, offering highly targeted treatment options and an efficient workflow,” Dr. Reddy said. “Although these results are quite preliminary, the potential of this system to revolutionize catheter ablation of complex ventricular arrhythmias is profound, potentially surpassing the current standard of care. The scientific community will benefit from the comprehensive results from the completed study.”
 
“Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes,” added Dr. Mickelsen. “With the promising early data for our VCAS study, in much the same way that PFA transformed AF, the FieldForce Ablation System is optimized to transform how ventricular arrhythmias are treated, offering hope to millions of patients worldwide. With the strong investor support, renown physician engagement and the groundbreaking potential of our technology, we are set to redefine the standards of cardiac ablation once again.”