The company can now evaluate the Affera mapping and ablation system with Sphere-9 catheter for treating sustained ventricular tachycardia (VT). This potentially life-threatening abnormal heart rhythm affects the lower chamber of the heart.
Medtronic designed Affera with Sphere-9 as an all-in-one, dual-energy pulsed field ablation (PFA) and radiofrequency (RF) ablation system. The high-density mapping catheter offers uses in cardiac electrophysiology ablation procedures. Several companies offer PFA technologies for treating AFib, another type of abnormal heart rhythm. The medtech giant now wants to move into VT as well.
Affera received CE mark in 2023. In January, CEO Geoff Martha reported “good progress” in bringing the Affera Sphere-9 PFA mapping and ablation catheter to the U.S. market this year. Medtronic filed for FDA approval for the system in the U.S. earlier in 2024 and had positive data for Affera in May.
More about the study and Medtronic ablation tech
The study will evaluate the treatment for patients who suffer from VT due to scarring from a previous myocardial infarction (heart attack). Primary endpoints include rate of device- or procedure-related serious adverse events (SAEs) following the ablation procedure and acute effectiveness at ablating the targeted VT. Investigators plan to follow patients enrolled at centers across the U.S. for six months post-ablation.
“We look forward to learning more about how the Sphere-9 Catheter, which offers physicians the ability to map and ablate with the option of choosing PF or RF, together with a large lattice-tip for managing the large target areas for ablation that typically present with VT, can be a useful tool for this challenging arrythmia,” said Dr. Khaldoun Tarakji, VP, chief medical officer, Cardiac Ablation Solutions at Medtronic. “Currently approved treatments for VT involve only RF energy and require physicians to use multiple mapping and ablation catheters with often long, inefficient procedure times.
“PFA technology and the innovative Sphere-9 design could have a significant impact on patient care.”
Medtronic also offers the PulseSelect PFA system, which this year became the first of its kind to win FDA approval. The company estimates the cardiac ablation market at $8 billion.
