Field Medical announced it has secured the FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system. Additionally, this technology has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP), which promotes preliminary, consistent strategic interactions with the FDA, as well as with patients, providers, and payers. This initiative supports swift progression and expansive availability of medical devices.
Field Medical was established by Dr. Steven Mickelsen, also known as the founder of Farapulse, where he currently holds the position of CEO. Under his leadership, his former PFA technology venture was acquired by Boston Scientific in 2021. Boston Scientific, Medtronic, and Johnson & Johnson MedTech have since achieved FDA clearance for their PFA technologies.
The FDA’s breakthrough nod and inclusion in TAP cover the FieldForce system as a treatment for sustained monomorphic scar-related ventricular tachycardia (VT). Field Medical claims that its system is uniquely designed for ablation of ventricular arrhythmias, a first in the field of PFA systems.
Field Medical’s innovation seeks to be the initial contact force PFA catheter tailored for use in the ventricle. This development is poised to offer treatment that is foreseeable, time-effective, and secure. With its FieldBending technology, the system applies complex, non-intuitive physics to deliver potent yet short-lived electrical fields. The company embarked on its first human trials in May.
“The FDA’s TAP pilot approval and breakthrough device designation for our FieldForce ablation system signify crucial achievements on our pathway to obtaining regulatory authorization,” affirmed Mickelsen. “This acknowledgment propels us closer to providing electrophysiologists with an advanced, targeted PFA instrument for rapid, accessible VT treatment.”