Medtronic has received FDA approval to conduct an early feasibility study of its Affera Mapping and Ablation System with the Sphere-9 Catheter for treating sustained ventricular tachycardia (VT), a life-threatening heart rhythm disorder affecting the lower heart chamber.
The Affera system integrates dual-energy pulsed field (PF) and radiofrequency (RF) ablation with high-density mapping capabilities. The system is designed for use in cardiac electrophysiology ablation procedures. The study aims to evaluate the Sphere-9 Catheter and Affera system in patients with VT resulting from scarring after a myocardial infarction.
Study Design and Endpoints
The early feasibility study will primarily assess the rate of serious adverse events related to the device or procedure and the acute success of ablating the targeted VT. Patients from various centers across the United States will be monitored for six months following the ablation procedure.
According to Khaldoun Tarakji, MD, MPH, vice president and chief medical officer of Medtronic's Cardiac Ablation Solutions business, the Sphere-9 Catheter offers physicians the ability to map and ablate using either PF or RF energy, along with a large lattice-tip for managing extensive target areas typical in VT cases. He added that currently approved VT treatments involve only RF energy and often require multiple catheters, leading to long and inefficient procedure times. The innovative Sphere-9 design and PFA technology could significantly improve patient care.
Current Treatment Landscape and Unmet Needs
VT is a potentially life-threatening arrhythmia that causes the heart to beat abnormally fast. Unlike atrial fibrillation, VT affects the lower heart chamber and often occurs after a heart attack or with advanced heart disease. Current treatments include medications and implanted defibrillators that deliver pacing or shocks. Catheter ablation is an established treatment option, but outcomes remain suboptimal due to limited innovation in ablation tools. This highlights a significant unmet need for improved patient care in VT management.
Prior Research and Future Implications
This early feasibility study builds on promising preclinical evidence in VT treatment and extensive research demonstrating the safety and efficacy of the Sphere-9 Catheter in treating persistent atrial fibrillation (Afib). The Sphere-9 Catheter received CE Mark approval in March 2023 for treating persistent Afib and is currently investigational in the U.S.
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System, noted that physicians need better tools to treat VT safely and effectively, and this early feasibility research is a positive step toward determining potential new options.
