Galway, Ireland, August 6, 2026
Medtronic has secured an expanded CE Mark indication for its Affera™ Mapping and Ablation System with the Sphere-9™ Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). The regulatory milestone expands the clinical application of Medtronic’s cardiac ablation platform and positions Sphere-9 as the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter to receive CE Marking for ventricular ablation, according to the company. The system combines high-definition cardiac mapping with both pulsed field (PF) and radiofrequency (RF) ablation capabilities in a single catheter, giving electrophysiologists flexibility when treating complex arrhythmias. The expanded European indication comes as Medtronic continues the global rollout of the Affera technology and advances a separate pivotal clinical program intended to support potential U.S. approval for ventricular tachycardia.
Sphere-9 Combines Mapping With Dual-Energy Ablation
The Affera Mapping and Ablation System with Sphere-9 Catheter is designed to integrate high-definition mapping and cardiac ablation within one platform. Sphere-9 allows physicians to map cardiac electrical activity and deliver either pulsed field or radiofrequency energy, potentially reducing the need to exchange multiple catheters during an ablation procedure. The large-tip focal catheter is intended to provide physicians with flexibility for treating different arrhythmia substrates, including cases that may be technically challenging. With the expanded CE Mark indication, European clinicians can now use the technology for ventricular arrhythmias in addition to its existing applications. The development is particularly significant for ventricular tachycardia, a potentially life-threatening rhythm disorder originating in the heart’s lower chambers. VT can occur following myocardial infarction or in association with advanced structural heart disease and may cause the heart to beat dangerously fast. While medications, implanted defibrillators and catheter ablation are established treatment approaches, Medtronic highlights continued unmet need for improved ventricular ablation technologies and outcomes.
FDA Breakthrough Status Supports U.S. Development
Alongside the European regulatory expansion, the U.S. FDA has granted Breakthrough Device Designation to the Sphere-9 Catheter for treatment of ventricular arrhythmias. The designation is intended to facilitate development and regulatory review of qualifying medical devices addressing serious or life-threatening conditions, although it does not constitute FDA marketing authorization for the ventricular indication. Medtronic is now enrolling patients in the Sphere VT U.S. pivotal trial, which will evaluate Sphere-9 for ventricular tachycardia and is designed to generate evidence supporting a potential future U.S. regulatory submission. The parallel European commercialization and U.S. clinical development strategy represents an important expansion of the Affera platform within Medtronic’s electrophysiology portfolio. The company is seeking to address both VT and premature ventricular complexes, which are early heartbeats originating from the ventricles and can disrupt normal cardiac rhythm.
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Medtronic Broadens Affera Platform Across Electrophysiology
The expanded indication represents another step in Medtronic’s strategy to broaden the clinical reach of the Affera and Sphere-9 electrophysiology platform. A key differentiating feature is the combination of two ablation modalities within a single mapping catheter. Radiofrequency ablation uses thermal energy to create targeted lesions, while pulsed field ablation uses electrical pulses to affect targeted cardiac tissue through a different mechanism. Providing both options within one system may give electrophysiologists greater procedural flexibility based on individual anatomy and arrhythmia characteristics. The CE Mark expansion also opens an additional ventricular arrhythmia market opportunity for Medtronic while the company builds clinical evidence through its ongoing U.S. pivotal program. Ventricular arrhythmia ablation remains a challenging area of electrophysiology, particularly in patients with complex underlying heart disease, making innovation in mapping and ablation technologies clinically important. With the new European indication, FDA Breakthrough Device Designation and active Sphere VT enrollment, Medtronic is advancing a coordinated global strategy for Sphere-9. The milestone strengthens the company’s presence in cardiac electrophysiology and next-generation ablation technology, while expanding treatment options available to physicians managing serious ventricular rhythm disorders.
Source: Medtronic press release
