Dual-Energy Mapping and Ablation Catheter Receives CE Mark for Ventricular Arrhythmias

Ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes, can be life-threatening and often occur in patients with advanced heart disease. Although catheter ablation is an established treatment, outcomes remain suboptimal and advances in ablation tools have been limited. Clinicians therefore continue to seek technologies that can simplify mapping and energy delivery in complex cardiac substrates. A newly expanded CE Mark indication now allows a single-catheter mapping-and-ablation system to treat ventricular arrhythmias.

Medtronic has announced an expanded CE Mark indication for the Affera Mapping and Ablation System with the Sphere-9 Catheter to include treatment of ventricular arrhythmias, specifically ventricular tachycardia and premature ventricular complexes. According to the company, Sphere-9 is the first CE-marked, all-in-one mapping and ablation catheter for ventricular procedures that combines a large-tip focal design with dual-energy capability. The expanded indication broadens use of the Affera platform across a wider range of arrhythmias in European markets.

The Affera Mapping and Ablation System with Sphere-9 Catheter integrates high-definition electroanatomic mapping with dual-energy ablation in a single tool. The catheter can deliver pulsed field (PF) and radiofrequency (RF) energy, enabling electrophysiologists to perform mapping and therapy without exchanging devices during cardiac ablation procedures. Its large-tip focal design is intended for precise lesion delivery while maintaining an efficient workflow in the electrophysiology laboratory.

Regulatory developments for the platform also include Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Sphere-9 Catheter in the treatment of ventricular arrhythmias, providing an expedited pathway for evaluation. In parallel, the Sphere VT U.S. pivotal trial is enrolling patients to assess the catheter for ventricular tachycardia and to support potential future approval in the United States. Medtronic notes the expansion responds to a critical unmet need in ventricular arrhythmia care and comes as clinical adoption of the technology grows.

“This milestone is a major step forward as we continue to expand the footprint of the Affera technology to more physicians and patients. Indication expansion to include ventricular arrhythmias unlocks another fast-growing market opportunity to keep building on our momentum, powered by the versatility, safety and efficiency of the Sphere-9 catheter,” said Rebecca Seidel, president of the Electrophysiology Therapies business at Medtronic.

“Physicians have long needed better tools for ventricular arrhythmias, and we’re proud to deliver a technology that addresses this unmet need and moves the needle on patient care. The unique features of Sphere-9, including a single catheter to map and ablate using radiofrequency or pulsed field energy and a large footprint, make it an excellent tool for a variety of arrhythmias, including those that may be challenging to treat,” said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic.