Global Finance News
07 Aug 2026, 16:10
# Medtronic Expands European Approval for Affera System to Treat Ventricular Arrhythmias
Medtronic (NYSE: MDT) announced an expanded CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 Catheter, allowing the technology to be used in Europe to treat ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes.
The expanded indication opens another potential growth market for Medtronic's cardiac ablation business as the company continues the global rollout of its Sphere-9 technology.
## Sphere-9 Gains First-of-Its-Kind CE Mark
According to Medtronic, Sphere-9 is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter to receive CE Mark authorization for ventricular ablation.
The system combines high-definition cardiac mapping with both pulsed field and radiofrequency ablation in a single catheter. This allows physicians to map abnormal electrical activity and select between the two energy sources during cardiac ablation procedures.
Medtronic said the technology could address an important unmet need in ventricular arrhythmias, where treatment options include medications, implanted defibrillators and catheter ablation.
## U.S. Clinical Trial Underway
Medtronic is also working toward expanding Sphere-9's ventricular indication in the United States.
The FDA has granted the catheter Breakthrough Device Designation for treating ventricular arrhythmias, providing an expedited regulatory pathway for the technology.
Enrollment is now underway in the Sphere VT pivotal trial, which will evaluate Sphere-9 for ventricular tachycardia and is intended to support a potential future U.S. approval.
The expanded European indication adds to Medtronic's broader push into next-generation electrophysiology. For the company, extending Sphere-9 beyond its existing applications could expand the addressable market for the Affera platform while strengthening its position in the growing cardiac ablation market.
Medtronic (NYSE: MDT) announced an expanded CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 Catheter, allowing the technology to be used in Europe to treat ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes.
The expanded indication opens another potential growth market for Medtronic's cardiac ablation business as the company continues the global rollout of its Sphere-9 technology.
## Sphere-9 Gains First-of-Its-Kind CE Mark
According to Medtronic, Sphere-9 is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter to receive CE Mark authorization for ventricular ablation.
The system combines high-definition cardiac mapping with both pulsed field and radiofrequency ablation in a single catheter. This allows physicians to map abnormal electrical activity and select between the two energy sources during cardiac ablation procedures.
Medtronic said the technology could address an important unmet need in ventricular arrhythmias, where treatment options include medications, implanted defibrillators and catheter ablation.
## U.S. Clinical Trial Underway
Medtronic is also working toward expanding Sphere-9's ventricular indication in the United States.
The FDA has granted the catheter Breakthrough Device Designation for treating ventricular arrhythmias, providing an expedited regulatory pathway for the technology.
Enrollment is now underway in the Sphere VT pivotal trial, which will evaluate Sphere-9 for ventricular tachycardia and is intended to support a potential future U.S. approval.
The expanded European indication adds to Medtronic's broader push into next-generation electrophysiology. For the company, extending Sphere-9 beyond its existing applications could expand the addressable market for the Affera platform while strengthening its position in the growing cardiac ablation market.
