California-based Field Medical has started the first-in-human (FIH) study for the FieldForce Ablation System to check its safety and performance.
The FieldForce Ablation System is said to be the first and only contact force pulsed field ablation (PFA) system for the time-efficient treatment of people with ventricular arrhythmias.
The Ventricular Catheter Ablation Study (VCAS) will assess the FieldForce system at Na Homolce Hospital in Prague, Czech Republic.
VCAS will recruit up to 60 patients at up to five sites worldwide. The system’s potential will be assessed to address the limitations of existing PFA and radiofrequency (RF) ablation systems.
It will be conducted in two parts where the VCAS-1 group concentrates on patients afflicted with ventricular tachycardia (VT).
On the other hand, the VCAS-2 group is aimed at those encountering frequent premature ventricular complexes (PVCs).
The trial seeks to establish that PFA can safely manage and enhance overall outcomes for patients with complex ventricular arrhythmias.
Field Medical CEO Steven Mickelsen said: “Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes.
“With the promising early data for our VCAS study, in much the same way that PFA transformed AF, the FieldForce Ablation System is optimised 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.”
Field Medical’s investigational PFA technology aims to offer a PFA catheter for optimal performance within the ventricle.
The technology allows predictable, efficient, and safe treatment options, the American medical technology firm said.
Field Medical’s FieldBending technology uses non-intuitive physics to deliver intense and brief electrical fields to reduce procedure times.
In September last year, the company closed its oversubscribed seed round with investments totalling $14m.
