Field Medical has announced that its FieldForce ablation system has been accepted into the US Food and Drug Administration (FDA)’s Total Product Life Cycle Advisory Program (TAP) pilot and been granted breakthrough device designation for sustained monomorphic scar-related ventricular tachycardia (VT).
A company press release notes that this recognition underscores the system’s “groundbreaking approach” to addressing life-threatening VT and the critical unmet needs for patients worldwide.
“The FDA’s TAP pilot acceptance and breakthrough device designation for the FieldForce ablation system represent pivotal milestones in our journey to regulatory approval,” said Steven Mickelsen, chief executive officer (CEO) of Field Medical. “This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA [pulsed field ablation] tool for fast, accessible VT care.”
“The FDA’s recognition of this breakthrough technology underscores the urgent need for innovation in treating complex, life-threatening VT,” added Vivek Reddy (Mount Sinai Health System, New York City, USA). “Field Medical’s ablation system has the potential to redefine VT care for physicians and patients alike.”
The release goes on to state that the FieldForce ablation system is the “first and only” PFA system specifically designed for VT ablation—and that current pharmacological therapies are limited in efficacy, with 30–50% of patients with VT not responding well to traditional drug treatments, highlighting the “pressing need” for innovative solutions like Field Medical’s system.
