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Promising Advances in Ventricular Tachycardia Treatment: Results from the VCAS Trial

Field Medical, Inc. has recently announced groundbreaking findings from the first human clinical trial concerning its innovative FieldForce™ Ablation System designed for treating ventricular tachycardia (VT). Published in the prestigious journal Circulation, the six-month results illustrate a striking 82% reduction in the recurrence of VT and a 98% decrease in arrhythmic burden among patients. These results were presented at the 20th Annual International Ventricular Tachycardia Symposium, highlighting their significance in the field of cardiac ablation.

Insights from the VCAS Study

The Ventricular Catheter Ablation Study (VCAS) is a prospective, multicenter trial aimed at assessing the safety and efficacy of the FieldForce™ system among patients suffering from VT. Unlike conventional techniques, the FieldForce™ utilizes a proprietary high-voltage, short-pulse wave form specifically designed to effectively navigate through dense scar tissue while minimizing thermal damage to surrounding areas.

Key findings from the study include:

• - 82% freedom from recurrent VT/Fibrillation or therapy with Implantable Cardioverter Defibrillator (ICD)
• - 98% reduction in total episodes of VT/FV
• - Only 11.5% of participants experienced primary safety events, with no complications linked to the therapy

Dr. Vivek Reddy, the principal investigator and an electrophysiologist at Mount Sinai, articulated the potential impact of these results, stating, "While this feasibility study is still in its early stages, the six-month outcomes are very promising. Achieving an 82% reduction in recurrence and 98% in arrhythmia burden with a non-thermal energy approach tailored for each tissue is an exceptional advancement in managing VT. It's significant that we observe evidence of PFA methods reaching deeply transmural scar tissue of the ventricle, a long-standing challenge with current energy sources. This fills me with cautious optimism regarding its future application in clinical settings.”

Field Medical's FieldForce™ Ablation System has also received the FDA’s Innovative Device Designation and was selected for its Total Product Lifecycle Pilot Program (TAP), paving the way for a robust evaluation and further studies in the field.

Significance of the Results

Dr. Steven Mickelsen, founder and Chief Technology Officer of Field Medical, commented on the importance of these initial viability data, stating, “It is rare that initial feasibility findings are published in a leading journal like Circulation, underscoring both the rigor and significance of this research. Our mission has always focused on marrying scientific credibility with innovation. These findings mark an essential milestone as we continue evaluating pulsed field ablation for its promise in enhancing patient outcomes with ventricular arrhythmias.”

Looking ahead, Field Medical is keen to explore additional applications of the FieldForce™ system beyond VT, with intentions to announce initial viability results for atrial fibrillation (AF) at significant upcoming scientific meetings in early 2026.

About the FieldForce™ Ablation System

The FieldForce™ Ablation System is recognized for its unique catheter design, which employs patented FieldBending™ technology aimed at delivering localized, brief, high-intensity electric fields. This next-generation pulsed field ablation system is designed to effectively treat both precise localized lesions and extensive transmural lesions found in the ventricle.

About Field Medical, Inc.

Founded in 2022, Field Medical is a clinical-stage medical technology company dedicated to advancing pulsed field ablation (PFA) solutions for complex cardiac arrhythmias. Their FieldForce™ system integrates focal catheter design with FieldBending energy technology to achieve safe, efficient, and precise ablations, driving improvements in treating both ventricular and atrial arrhythmias. In 2024, Field Medical was granted Innovative Device Designation and entered the FDA's TAP program for its application targeting ventricular tachycardia.

For more information, please visit www.fieldmedicalinc.com and follow us on LinkedIn, X, and YouTube. It is crucial to note that the FieldForce™ Ablation System remains an investigational device, and its use is limited to research purposes as mandated by federal law.

In conclusion, the results from the VCAS trial represent a significant step forward in the treatment of ventricular tachycardia, indicating the potential for improved patient outcomes and paving the way for continued exploration and innovation in cardiac therapies.