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The FieldForce ablation system, according to the company, is the first, only PFA system specifically designed for ventricular arrythmia ablation.
December 6, 2024
By: Sam Brusco
Associate Editor
Field Medical, a developer of pulsed field cardiac catheter ablation technology, announced that its FieldForce ablation system was accepted into the U.S. Food and Drug Administration’s Total Product Life Cycle Advisory Program (TAP) Pilot and granted breakthrough status for sustained monomorphic scar-related ventricular tachycardia (VT).
The FieldForce ablation system, according to the company, is the first, only PFA system specifically designed for ventricular arrythmia ablation. Catheter ablation has been demonstrated to be superior to medical therapy in patients at risk of sudden cardiac death (SCD) from VT (Sapp et al., 2024). SCD, which accounts for approximately 450,000 deaths annually in the U.S. alone (Mason et al., 2022) is often attributed to VT.
Current pharmacological therapies are limited in efficacy, with 30-50% of patients with VT not responding well to traditional drug treatments (Kircher et al., 2023).
FieldForce features a single-point contact force PFA catheter with an innovative design utilizing proprietary FieldBending technology to deliver targeted, brief, high-intensity electric fields. This next-gen PFA tech was designed to deliver both precise targeted lesions and large volume transmural lesions in the ventricle.
Field Medical was founded 2022 and led by Dr. Steven Mickelson, a pioneer in pulsed field electric field technology.
“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 Dr. Mickelsen, CEO. “This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care.”
Dr. Vivek Reddy, Director of Electrophysiology at Mount Sinai Health System, added, “The FDA’s recognition of this breakthrough technology underscores the urgent need for innovation in treating complex, life-threatening ventricular tachycardia. Field Medical’s ablation system has the potential to redefine VT care for physicians and patients alike.”
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