CARDIFF-BY-THE-SEA, Calif– Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic. The Ventricular Catheter Ablation Study, VCAS, will enroll up to 60 patients at up to 5 sites world-wide. The VCAS investigational study is a critical step towards demonstrating safety and performance of the FieldForce™ Ablation System, developed specifically to address the limitations of existing pulsed field ablation (PFA) and radiofrequency (RF) ablation systems, including a more time efficient treatment protocol for the treatment of ventricular arrhythmias. Preliminary results will be presented on May 16, 2024, at the Heart Rhythm Scientific Sessions in Boston, Mass.
“The FieldForce Ablation System, as the first contact force PFA system for ventricular ablation, is demonstrating significant promise early in our trials,” said Vivek Reddy, MD, Director of Electrophysiology for the Mount Sinai Health System. “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. 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.”
PFA has revolutionized the treatment of atrial fibrillation (AF) over the past decade, thanks to pioneering work by Field Medical CEO Steven Mickelsen, MD, founder of Farapulse which was subsequently acquired by Boston Scientific. His development of PFA technology marked a significant shift in cardiac electrophysiology, enhancing safety and reducing procedure times. This innovation set a new standard in the industry, leading to widespread adoption and the transformation of ablation practices. With PFA’s proven success in atrial settings, Field Medical is now poised to extend these benefits to ventricular arrhythmias, signaling a pivotal evolution in the management of complex ventricular cardiac conditions.
It is estimated that ventricular arrhythmia impact over 6 million patients in the US and Europe. Ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular contractions (PVCs), and pose a substantial risk, often leading to sudden cardiac death if not adequately managed. Current ventricular catheter ablation methods involve lengthy procedures and significant risks associated with thermal ablation, like conventional RF ablation. Field Medical’s PFA technology aims to address these challenges by providing the first and only contact force PFA catheter optimized to work in the ventricle. This novel technology may enable predictable, time efficient, and safe treatment option. FieldBending™ takes advantage of non-intuitive physics to deliver intense, yet brief, electric fields designed to safely reduce procedure times dramatically.
“Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes,” said Steven Mickelsen MD, CEO of Field Medical. “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.”
