Field Medical's First-in-Human VCAS Trial: Focal Pulsed Field Ablation for Ventricular Tachycardia

Field Medical's VCAS system brings focal pulsed field ablation to ventricular tachycardia — with FDA Breakthrough Device Designation, TAP Pilot acceptance, and expansion into atrial fibrillation.

April 10, 2026

11

min read

By

bioaccess® Team

first-in-human trial

Field Medical VCAS

pulsed field ablation

ventricular tachycardia

FDA Breakthrough Device

**Key Takeaways**

• • Field Medical's VCAS is a focal pulsed field ablation system for scar-related ventricular tachycardia
• • 6-month outcomes presented as late-breaking data at VT Symposium 2025
• • FDA Breakthrough Device Designation granted in 2024, plus TAP Pilot Program acceptance
• • Expanding to atrial fibrillation with Field PULSE trial and late-breaking data at AF Symposium 2026
• • Results also presented at Heart Rhythm 2025 in April

Trial overview: VCAS focal pulsed field ablation for ventricular tachycardia

Field Medical has developed the VCAS (Ventricular Cardiac Ablation System), a novel focal pulsed field ablation (PFA) device engineered specifically for the treatment of scar-related ventricular tachycardia (VT). VT is a life-threatening arrhythmia that affects patients with structural heart disease and remains one of the most challenging conditions to treat with conventional ablation technologies.

Pulsed field ablation represents a paradigm shift in cardiac electrophysiology. Unlike radiofrequency ablation (RFA) or cryoablation, PFA uses ultra-short, high-voltage electrical pulses to create lesions through irreversible electroporation — selectively destroying cardiac tissue while sparing critical surrounding structures such as the esophagus, phrenic nerve, and coronary arteries.

VCAS focal PFA technology for scar-related VT

The VCAS system is differentiated by its focal delivery approach, which is specifically designed for the complex ventricular substrate associated with scar-related VT. While other PFA systems are being developed primarily for atrial fibrillation, Field Medical recognized the unmet need in the VT space — where existing technologies often fail to achieve durable lesions in scarred myocardium.

• Focal pulsed field ablation designed for ventricular substrate
• Targets scar-related VT — a condition with high recurrence rates after conventional ablation
• Selective tissue ablation preserving surrounding critical structures
• Potential for more complete and durable lesions in fibrotic tissue

6-month outcomes presented at VT Symposium 2025

The first-in-human VCAS trial reached a significant milestone when 6-month outcomes were presented as late-breaking data at the VT Symposium 2025 in October. The presentation generated substantial interest from the electrophysiology community, as it represented the first clinical evidence of focal PFA efficacy in ventricular tachycardia.

Additional data from the VCAS program was presented at Heart Rhythm 2025 in April, further establishing the clinical evidence base for this novel technology. The consistent presentation at major international conferences underscores the significance of the VCAS data and the medical community's interest in PFA for VT.

FDA Breakthrough Device Designation & TAP Pilot Program

Field Medical's VCAS system has received two significant FDA designations that accelerate its path to US market approval:

• FDA Breakthrough Device Designation (2024): Priority review, interactive FDA communication, and more flexible study designs
• FDA TAP (Total Product Life Cycle Advisory Program) Pilot: Enhanced engagement with FDA throughout the entire product lifecycle, from development through post-market surveillance

**What is the FDA TAP Pilot Program?**

The Total Product Life Cycle Advisory Program (TAP) is an FDA initiative that provides device manufacturers with enhanced regulatory engagement throughout the product lifecycle. For companies like Field Medical, TAP acceptance means more frequent and substantive interactions with FDA reviewers, potentially accelerating the path from first-in-human trials to market approval.

Expansion from VT to atrial fibrillation

Building on the VCAS VT data, Field Medical is expanding its PFA platform into atrial fibrillation (AF) with the Field PULSE trial. Late-breaking data from the AF program was presented at the AF Symposium in February 2026, demonstrating the versatility of Field Medical's PFA technology across different cardiac arrhythmias.

This expansion strategy — proving the technology in a challenging indication (VT) before moving to a larger market (AF) — mirrors the development pathway that many successful early feasibility and FIH programs follow when entering Latin American markets first.

bioaccess® and electrophysiology FIH trials in Latin America

Field Medical's VCAS program highlights the growing importance of FIH clinical trials for electrophysiology devices. bioaccess® has extensive experience supporting cardiac device companies with first-in-human trials across Latin America, where regulatory timelines and costs provide significant advantages for early-stage clinical development.

• Regulatory strategy for cardiac device trials across LATAM countries
• Access to world-class electrophysiology investigators and cardiac catheterization labs
• Full clinical operations support including monitoring and data management
• FDA submission support for IDE applications and Breakthrough Device designations
• Market access strategy for post-trial commercialization via bioaccess® MARKET ACCESS ACCELERATOR™

**Planning an electrophysiology FIH trial?**

bioaccess® supports medtech companies conducting first-in-human trials for cardiac ablation, structural heart, and electrophysiology devices in Latin America. Contact bioaccess® today or explore our FIH FastTrack program.

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