Salute e Benessere
Field Medical's FieldForce™ Ablation System Earns FDA TAP Pilot Acceptance and Breakthrough Device Designation for the Treatment of Ventricular Tachycardia.
Dr. Vivek Reddy , Director of Electrophysiology at Mount Sinai Health System, added, "The FDA's recognition of this breakthrough technology underscores the urgent need for innovation in treating complex, life-threatening ventricular tachycardia. Field Medical's ablation system has the potential to redefine VT care for physicians and patients alike."
The is the first and only PFA system specifically designed for ventricular arrhythmia ablation. Catheter ablation has been shown to be superior to medical therapy in patients at risk of sudden cardiac death (SCD) from VT (Sapp et al., 2024). SCD, which accounts for approximately 450,000 deaths annually in the United States alone (Mason et al., 2022) is often attributed to VT. Current pharmacological therapies are limited in efficacy, with 30-50% of patients with VT not responding well to traditional drug treatments (Kircher et al., 2023). The emerging science highlights the pressing need for innovative solutions like the FieldForce™ Ablation System.
Founded in 2022, Field Medical is advancing next-generation pulsed field ablation (PFA) technologies to address the complex needs of modern cardiac ablation. The company is led by Dr.
Steven Mickelsen , a pioneer in pulsed electric field technology and one of the foremost innovators in the field. Dr. Mickelsen's foundational work in PFA established the basis for modern advancements in the technology, which Field Medical continues to refine with its groundbreaking solutions. The company's proprietary FieldBending™ technology and comprehensive product portfolio, including the FieldForce™ Catheter, FieldForce™ Ablation System, and FieldFlex™ Sheath, are designed to expand PFA applications beyond atrial fibrillation to treat complex ventricular arrhythmias. Field Medical is committed to advancing patient outcomes through innovation, transforming cardiac care for the millions impacted by these life-threatening conditions worldwide.
The FieldForce Ablation System features a single-point contact force PFA catheter with an innovative design utilizing proprietary FieldBending™ technology to deliver targeted, brief, high-intensity electric fields. This next-generation PFA technology was designed to deliver both precise targeted lesions and large volume transmural lesions in the ventricle.
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The FieldForce™ PFA Ablation System is an investigational device and is limited by Federal (or United States ) Law to investigational use.
Holly Windler
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References:
Mason, J., et al. (2022). "Trends in Sudden Cardiac Death Due to Ventricular Tachycardia and Fibrillation in
the United States ." .
Kircher, A., et al. (2023). "Efficacy of Antiarrhythmic Medications in the Treatment of Ventricular Tachycardia: A Review."
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Sapp, J., et al. (2024). "Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia."
DOI: 10.1056/NEJMoa2409501.
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