Field Medical has announced that its FieldForce ablation system has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of sustained monomorphic scar-related ventricular tachycardia (VT). The company also secured acceptance into the FDA's Total Product Life Cycle Advisory Program (TAP) pilot, which provides early and frequent strategic engagement with regulators to expedite development and patient access.
The FieldForce system is the first and only pulsed field ablation (PFA) technology specifically engineered for ventricular arrhythmia ablation, representing a significant advancement in addressing life-threatening cardiac conditions that affect hundreds of thousands of patients worldwide.
Addressing a Critical Unmet Need
Ventricular tachycardia is a serious cardiac arrhythmia that contributes significantly to sudden cardiac death (SCD), which accounts for approximately 450,000 deaths annually in the United States alone. Current pharmacological therapies have limited efficacy, with 30-50% of VT patients not responding adequately to traditional drug treatments.
"The FDA's recognition of this breakthrough technology underscores the urgent need for innovation in treating complex, life-threatening ventricular tachycardia," said Dr. Vivek Reddy, Director of Electrophysiology at Mount Sinai Health System. "Field Medical's ablation system has the potential to redefine VT care for physicians and patients alike."
Recent research published in the New England Journal of Medicine has demonstrated that catheter ablation is superior to medical therapy in patients at risk of sudden cardiac death from VT, highlighting the clinical importance of advancing ablation technologies for this condition.
Innovative Technology Platform
The FieldForce Ablation System features a single-point contact force PFA catheter with an innovative design utilizing proprietary FieldBending technology. This approach delivers targeted, brief, high-intensity electric fields designed to create both precise targeted lesions and large volume transmural lesions in the ventricle.
Unlike conventional thermal ablation methods, PFA uses high-power electrical pulses that puncture cell membranes of cardiomyocytes through electroporation. This approach is considered safer than radiofrequency or cryoballoon ablation because it is more specific for myocardial tissue, potentially limiting damage to surrounding structures.
"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. Steven Mickelsen, CEO of Field Medical. "This recognition advances our vision of equipping electrophysiologists with a next-generation, focal PFA tool for fast, accessible VT care."
Clinical Development Progress
Field Medical began enrolling patients in its first-in-human clinical trial in May 2024, with plans to include up to 60 participants across five global sites. The study aims to evaluate the safety and effectiveness of the FieldForce system in treating ventricular tachycardia.
The company was founded in 2022 by Dr. Mickelsen, who is recognized as a pioneer in pulsed electric field technology. Notably, Dr. Mickelsen previously founded Farapulse, another PFA technology developer that was acquired by Boston Scientific in 2021.
Growing PFA Landscape
The breakthrough designation for Field Medical's technology comes amid significant developments in the broader PFA market. Within the past 12 months, the FDA has approved three other PFA systems for atrial fibrillation: Farapulse (Boston Scientific), PulseSelect (Medtronic), and Varipulse (Johnson & Johnson MedTech).
However, Field Medical's system is distinguished by its specific focus on ventricular arrhythmias, which present different challenges than atrial fibrillation and require specialized approaches for effective treatment.
Funding and Future Outlook
In 2023, Field Medical secured $14 million in an oversubscribed funding round to support the development of its FieldBending technology. The FDA breakthrough designation and TAP acceptance are expected to accelerate the company's regulatory pathway and potentially bring this innovative technology to patients sooner.
The FieldForce PFA Ablation System remains an investigational device limited by U.S. law to investigational use. If approved, it would represent a significant advancement in the treatment options available for patients suffering from ventricular tachycardia, a condition with substantial mortality risk and limited effective therapies.
