The Investor
26 Apr 2026, 20:02
Medtronic reported positive clinical progress for its Affera™ cardiac ablation technologies, highlighting new data and regulatory milestones at the Heart Rhythm Society 2026 meeting. Interim results showed that 65.5% of patients treated with the Sphere-9™ catheter remained free from ventricular tachycardia recurrence after six months.
The Sphere-9 catheter also received FDA Breakthrough Device Designation for treating ventricular tachycardia, while a U.S. pivotal trial has been approved. Additional data for the Sphere-360™ catheter demonstrated high durability in atrial fibrillation procedures, with consistent outcomes across different patient anatomies.
Medtronic also announced the launch of a new global study to evaluate the technology in a broader group of atrial fibrillation patients, supporting continued expansion and clinical validation of its cardiac rhythm treatment portfolio.
PRNewswire
The Sphere-9 catheter also received FDA Breakthrough Device Designation for treating ventricular tachycardia, while a U.S. pivotal trial has been approved. Additional data for the Sphere-360™ catheter demonstrated high durability in atrial fibrillation procedures, with consistent outcomes across different patient anatomies.
Medtronic also announced the launch of a new global study to evaluate the technology in a broader group of atrial fibrillation patients, supporting continued expansion and clinical validation of its cardiac rhythm treatment portfolio.
PRNewswire
