The FDA also accepted the technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.
Field Medical was founded by Dr. Steven Mickelsen, the founder of Farapulse. Mickelsen also serves as CEO. He led his previous PFA technology developer to an acquisition by Boston Scientific in 2021. Boston Scientific, Medtronic and Johnson & Johnson MedTech now have their PFA technology FDA-cleared.
The FDA breakthrough nod and TAP acceptance cover the FieldForce system for sustained monomorphic scar-related ventricular tachycardia (VT). Field Medical says its system represents the first and only PFA system designed specifically for ventricular arrhythmia ablation.
Field Medical’s technology aims to become the first and only contact force PFA catheter optimized to work in the ventricle. It believes this could lead to predictable, time-efficient and safe treatment. Field Medical’s FieldBending technology utilizes non-intuitive physics to deliver intense, yet brief, electrical fields. The company began first-in-human studies in May.
“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 Mickelsen. “This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care.”
