Designed to address life-threatening ventricular tachycardia, the system has been granted FDA Breakthrough Device Designation and accepted into the Total Product Life Cycle Advisory Program pilot, recognizing its approach to unmet patient needs.
Summary: Field Medical’s FieldForce Ablation System, a pulsed field ablation technology for ventricular tachycardia (VT), has been granted FDA Breakthrough Device Designation and accepted into the TAP pilot program. The system uses proprietary FieldBending technology to deliver precise and large-volume lesions for ventricular arrhythmia ablation. With VT contributing to approximately 450,000 deaths annually in the US and limited efficacy of current treatments, the device offers a potential alternative for addressing this unmet need in patient care.
Key Takeaways:
- FDA Recognition: The FieldForce Ablation System received Breakthrough Device Designation and acceptance into the TAP pilot for its potential to address life-threatening VT.
- Innovative Technology: The system utilizes FieldBending technology to deliver precise and large-volume lesions, advancing ventricular arrhythmia ablation techniques.
- Unmet Need: VT remains a significant cause of sudden cardiac death, with limited effective treatment options, highlighting the urgency for innovative solutions like this device.
Field Medical Inc, a pulsed field cardiac catheter ablation technology developer, announced today that its FieldForce Ablation System has been accepted into the US Food and Drug Administration’s (FDA) Total Product Life Cycle Advisory Program (TAP) pilot and granted Breakthrough Device Designation for sustained monomorphic scar-related ventricular tachycardia (VT).
This recognition underscores the system’s approach to addressing life-threatening VT and the critical unmet needs for patients worldwide.
“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,” says Vivek Reddy, MD, director of electrophysiology at Mount Sinai Health System, in a release.
Ablation Technology Targets Gaps in VT Treatment
The FieldForce Ablation System is specifically designed for ventricular arrhythmia ablation. It features a single-point contact force pulse field ablation catheter utilizing proprietary FieldBending technology to deliver targeted, brief, high-intensity electric fields. This next-generation pulse field ablation technology was designed to deliver both precise targeted lesions and large-volume transmural lesions in the ventricle.
Catheter ablation has been shown to be superior to medical therapy in patients at risk of sudden cardiac death from VT. Sudden cardiac death, which accounts for approximately 450,000 deaths annually in the United States alone 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. The emerging science highlights the need for innovative solutions like the FieldForce Ablation System.
The FieldForce PFA Ablation System is an investigational device and is limited by federal law to investigational use.
Photo caption: FieldForce Ablation System
Photo credit: Field Medical
