Field Medical announced that it began the first-in-human study of its FieldForce pulsed field ablation (PFA) system. The company began its study evaluating FieldForce at Na Homolce Hospital in Prague, Czech Republic. It expects the VCAS study to enroll up to 60 patients at up to five sites around the world.
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Cardiff-by-the-Sea, California-based Field Medical aims to demonstrate the safety and performance of its PFA system. Namely, it wants to address the limitations of existing PFA and radiofrequency (RF) ablation systems. That includes a more time-efficient treatment protocol for the treatment of ventricular arrhythmias.
Field Medical was founded in 2022 by Dr. Steven Mickelsen, the founder of Farapulse. Mickelsen also serves as CEO. He led his previous pulsed-field ablation (PFA) technology developer to an acquisition by Boston Scientific in 2021. Now, the company wants to take on the likes of Boston Scientific and Medtronic, who now have their PFA technology FDA-cleared.
The company’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.
Dr. Vivek Reddy, director of EP at Mount Sinai, said the system already demonstrated “significant promise” early in the trials. Reddy says the system hast he potential to “revolutionize catheter ablation of complex ventricular arrhythmias.” He even said it could surpass the current standard of care.
“Our vision at Field Medical is to transform VT ablation into a widely available, one-hour outpatient procedure with improved safety outcomes,” said Mickelsen. “With the promising early data for our VCAS study, in much the same way that PFA transformed AF, the FieldForce Ablation System is optimized to transform how ventricular arrhythmias are treated, offering hope to millions of patients worldwide. With the strong investor support, renown physician engagement and the groundbreaking potential of our technology, we are set to redefine the standards of cardiac ablation once again.”
