FDA Approves Early Feasibility Study of Medtronic's Affera Mapping and Ablation System with Sphere-9 Catheter for Ventricular Tachycardia

Integrated Sphere-9 Catheter for Mapping and Ablation

Medtronic (NYSE: MDT) recently announced FDA approval for an early feasibility study to evaluate its Affera system for treating VT.

The company can now evaluate the Affera mapping and ablation system using the Sphere-9 catheter for the treatment of persistent ventricular tachycardia (VT), a potentially life-threatening abnormal heart rhythm that affects the lower chambers of the heart.

Medtronic integrates Affera with Sphere-9 into a unified, dual-energy Pulsed Field Ablation (PFA) and Radiofrequency (RF) ablation system. The high-density mapping catheter can be used in cardiac electrophysiology ablation procedures. Several companies offer PFA technology for treating AFib (another type of abnormal heart rhythm). This medical technology giant now also aims to enter the VT market.

Affera Obtained CE Mark in 2023. In January this year, CEO Geoff Martha reported "good progress" in bringing the Affera Sphere-9 PFA mapping and ablation catheter to the U.S. market in 2024. Medtronic applied for FDA approval of the system in the United States early in 2024 and received positive data for Affera in May.

The study will evaluate the treatment of patients with VT due to prior myocardial infarction (heart attack) scarring. The primary endpoints include the incidence of severe adverse events (SAEs) related to the device or procedure after ablation and the acute effectiveness of ablating the target VT. Researchers plan to follow up with patients registered at centers across the U.S. for six months post-ablation.

Khaldoun Tarakji, MD, Vice President and Chief Medical Officer of Medtronic's Cardiac Ablation Solutions, stated: "We look forward to learning more about how the Sphere-9 catheter can become a valuable tool for this challenging arrhythmia. Currently approved VT treatments only involve radiofrequency energy and require physicians to use multiple mapping and ablation catheters, often resulting in long and inefficient procedures. The 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 receive FDA approval. The company estimates the cardiac ablation market at $8 billion.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production: Ling Wujuan