Medtronic yesterday announced an expanded CE Mark indication for the Affera™ Mapping and Ablation System with Sphere-9™ Catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs).
The Sphere-9 catheter is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter CE marked for ventricular ablation.
Additionally, in recognition of the critical unmet need for ventricular arrhythmia treatments, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias, which provides an expedited regulatory pathway for the technology in this patient population. The Sphere VT pivotal trial to evaluate Sphere-9 for the treatment of VT and support future approval in the US is now enrolling patients.
The Affera Mapping and Ablation System with Sphere-9 Catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping catheter for use in cardiac ablation procedures.
VT is a potentially life-threatening arrhythmia that causes the heart to beat abnormally fast. Unlike atrial fibrillation, VT affects the lower chamber of the heart and often presents after a heart attack or together with other advanced heart diseases.
VT patients are often treated with medications and may receive life-saving therapies from implanted defibrillators in the form of pacing or shocks.
Catheter ablation for VT is an established treatment option, but outcomes have remained suboptimal with little ablation tool innovation in recent years. As a result, a significant unmet need exists to improve patient care.
PVCs are extra or early heartbeats that start in the heart's lower chambers (ventricles), briefly disrupting normal rhythm and potentially causing a flutter-like feeling in the chest.
