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Promising Results from the First VCAS Study

Field Medical, Inc. has recently published the six-month results from its pioneering Ventricular Catheter Ablation Study (VCAS). The findings, featuring promising outcomes from their FieldForce™ Pulsed Field Ablation System, were presented at the 20th Annual International Symposium on Ventricular Arrhythmias and published in the esteemed journal, Circulation.

The VCAS represents a significant advancement in treatment techniques for patients suffering from ventricular tachycardia (VT). Over the study's six months, the FieldForce system demonstrated an impressive 82% freedom from VT/VF recurrences, coupled with a remarkable 98% reduction in arrhythmia burden. These results mark a substantial leap forward in clinical efficacy.

Key Findings

The study provided crucial insights into the application of a novel high-voltage short-pulse waveform technology. Developed by Field Medical, this cutting-edge system is engineered to penetrate dense scar tissue while minimizing thermal injury to surrounding healthy areas. Among the critical findings:

• - Reported 82% freedom from VT/VF recurrences.
• - Notably, an all-time low of 98% reduction in VT/VF episode burden was observed.
• - Only 11.5% of participants experienced a primary safety event, with no complications directly linked to the therapy.

Dr. Vivek Reddy, Co-Principal Investigator and an Electrophysiologist at Mount Sinai in New York, expressed optimism regarding these results. He noted how the study presents early evidence that PFA (Pulsed Field Ablation) can reach deep, transmural scar tissue in the ventricles, a longstanding challenge in current treatment methodologies. Dr. Reddy remarked, “Achieving such high rates of recurrence freedom and episodes reduction with a non-thermal, tissue-selective energy displays a significant milestone in VT therapy.”

FDA Evaluation and Future Directions

The FieldForce Abation System has garnered Breakthrough Device Designation from the FDA, indicating the potential transformative impact that this technology interjects into the cardiovascular management space. Furthermore, the system is included in the FDA's Total Product Life Cycle (TAP) Pilot Program, advancing towards a regulatory study for comprehensive assessment.

An unusual feat for initial feasibility data, the publication of findings in Circulation underscores the rigorous validation of the outcomes achieved. Dr. Steven Mickelsen, founder and Chief Technology Officer at Field Medical, affirmed that merging scientific credibility with innovative practices remains central to the company’s mission. He further emphasized that such an achievement cements a pivotal milestone as they continue evaluating the possibilities of PFA technology in reshaping patients' treatment experiences for ventricular arrhythmias.

Looking ahead, Field Medical is exploring additional applications of the FieldForce Ablation System beyond VT. They anticipate releasing preliminary results from the feasibility of the system in treating atrial fibrillation (AF) at a major scientific conference in early 2026. As advancements unfold, the medical community keenly observes the progress of this innovative technology combating complex cardiac issues.

About Field Medical, Inc.

Founded in 2022, Field Medical is a clinical-stage med-tech company committed to advancing Pulsed Field Ablation (PFA) solutions for intricate heart rhythm disorders. The FieldForce Ablation System integrates focused catheter design with proprietary FieldBending™ energy aimed at delivering safe, efficient, and precise ablation. By 2024, Field Medical achieved the prestigious Breakthrough Device Designation for ventricular tachycardia indications and entered into the FDA TAP Pilot Program.

For additional details, visit Field Medical, Inc. or follow them on LinkedIn, X, and YouTube. The FieldForce™ Ablation System remains an investigational device limited to investigational use only per federal law.