Medical Devices DECODED
Previous edition: 13 May 2024
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Field Medical begins ventricular PFA technology trial
The FieldForce Ablation System is intended for the treatment of life-threatening ventricular arrhythmias.
Field Medical has announced the commencement of first-in-human trials for its FieldForce pulsed field ablation (PFA) system at Na Homolce Hospital in Prague, Czech Republic.
FieldForce, which is said to be the first and only contact force PFA system, is designed for the treatment of life-threatening ventricular arrhythmias such as ventricular tachycardia (VT) and premature ventricular contractions (PVCs).
As part of the Ventricular Catheter Ablation Study (VCAS), the company will enrol up to 60 patients across five global sites.
This study is pivotal in demonstrating the safety and performance of the FieldForce ablation system, which aims to overcome the limitations of current PFA and radiofrequency ablation systems.
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.”
Field Medical's PFA technology offers a new solution with the first contact force PFA catheter optimised for the ventricle, potentially providing a predictable, time-efficient, and safer treatment option.
The VCAS study is a prospective safety and feasibility trial assessing the FieldForce Ablation System in patients with ventricular arrhythmias.
It is divided into two groups: VCAS-I, focusing on VT patients, and VCAS-II, targeting those with frequent PVCs.
Last year, Field Medical closed an oversubscribed seed round totalling $14m to help advance its catheter ablation platform.
Unnamed private investors led the convertible note investment, which aimed to support the company’s clinical development of the FieldBending technology.
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