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Field Medical's FieldForce™ Ablation System: A New Hope for Ventricular Tachycardia

Field Medical Inc. has made a remarkable stride in cardiac care with its FieldForce™ ablation system, which has just been recognized by the FDA as a TAP Pilot and designated as a breakthrough device. This innovation is set to transform the treatment landscape for patients suffering from life-threatening ventricular tachycardias (VT).

What is the FieldForce™ Ablation System?

The FieldForce™ system is the first of its kind in the realm of pulsed field ablation (PFA) technology. Designed explicitly for the ablation of heart rhythm disorders, its unique single-contact catheter utilizes Field Medical's proprietary FieldBending™ technology. This allows it to create targeted, highly effective electrical fields that help restore normal heart rhythm by eliminating troublesome tissue.

Significance of FDA's TAP Pilot and Breakthrough Designation

Receiving the FDA’s TAP Pilot acceptance and breakthrough designation is a significant milestone for Field Medical. The TAP program is aimed at accelerating patient access to innovative medical devices that provide a more effective treatment compared to existing options. This recognition reflects a critical commitment from the FDA to enhance access to safe and useful therapies for patients who desperately need them.

Dr. Steven Mickelsen, CEO of Field Medical, expressed his enthusiasm, stating, “These recognitions are pivotal as they drive our vision forward—equipping electrophysiologists with next-generation PFA tools that facilitate rapid and accessible VT treatment.”

Addressing a Growing Health Crisis

Ventricular tachycardia is a serious cardiac condition that can lead to sudden cardiac death (SCD). In the U.S. alone, SCD claims approximately 450,000 lives annually, frequently linked to ventricular tachycardia. Unfortunately, current pharmacological treatments only show effectiveness in 50-70% of patients, leading to a pressing demand for better solutions. The FieldForce™ system aims to fulfill this requirement by delivering superior results over traditional medication therapies.

Dr. Vivek Reddy, Director of Electrophysiology at the Mount Sinai Health System, underscored the urgent need for innovations in treating complex, life-threatening VT. He stated, “The FDA's acknowledgment of this groundbreaking technology highlights the pressing need for improvements in VT treatment, and the Field Medical ablation system can redefine care for both physicians and patients.”

The Future of Cardiac Care

Field Medical, which was founded in 2022, has emerged as a leader in the development of cutting-edge PFA technology. Their comprehensive approach is not just limited to treating atrial fibrillation but also encompasses complex ventricular arrhythmias. The technology is built on Dr. Mickelsen's pioneering work in pulsed electric field technology, a foundation that has enabled these modern advances.

The company’s expansive product offering, including the FieldForce™ catheter and FieldFlex™ sheath, aims to improve patient outcomes globally. As they progress in their mission to innovate cardiac solutions, the FieldForce™ ablation system represents a beacon of hope for countless individuals suffering from life-threatening arrhythmias.

For more information about Field Medical Inc. and its groundbreaking solutions, visit their website or follow them on LinkedIn and X. It's important to note that the FieldForce™ PFA ablation system is currently classified as a research device and is intended solely for research purposes under federal law.

Media Contact

Holly Windler
619-929-1275

References

• - Mason, J., et al. (2022). “Trends in Sudden Cardiac Death Due to Ventricular Tachycardia and Fibrillation in the United States.” Circulation Research.
• - Kircher, A., et al. (2023). “Efficacy of Antiarrhythmic Medications in the Treatment of Ventricular Tachycardia A Review.” Journal of the American College of Cardiology.
• - Sapp, J., et al. (2024). “Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia.” The New England Journal of Medicine. DOI 10.1056/NEJMoa2409501.