US-based Field Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for the FieldForce ablation system.
FieldForce is the first PFA system specifically designed for the ablation treatment of ventricular tachycardia (VT). In May 2024, California-based Field Medical began enrolling up to 60 patients at up to five global sites for a trial of the system.
Recent research published in the New England Journal of Medicine found that in VT patients, an initial strategy of catheter ablation led to a lower risk of a composite primary end-point event than antiarrhythmic drug therapy.
Field Medical also announced its acceptance into the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot.
The primary goal of the agency’s TAP accelerator is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and by facilitating engagement with other key parties for developers of devices of public health importance.
The FDA stated that in meeting this goal, the 58 companies with devices inducted into the accelerator to date gain access to FDA TAP advisors that provide solutions-focused engagement tailored to each TAP participant’s needs in advancing devices to market and patient access.
Field Medical CEO Dr Steven Mickelsen said: "The FDA's TAP Pilot acceptance and breakthrough device designation for the FieldForce ablation system represent pivotal milestones in our journey to regulatory approval.
"This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care."
In 2023, Field Medical closed an oversubscribed funding round totalling $14m, which it said would go towards the development of its FieldBending technology.
Elsewhere in PFA, this month the Texas Cardiac Arrhythmia Institute (TCAI) at St David’s Medical Centre became the first clinic in the US to use Medtronic’s Affera mapping and ablation system with the Sphere-9 catheter since the device’s FDA approval in October 2024.
Last month, Boston Scientific resumed enrolment for the AVANT GUARD clinical trial of its Farapulse PFA system as a first-line treatment for persistent atrial fibrillation, after it was paused in October 2024 to “assess a few unanticipated observations”.
