Medtronic Announces Expanded CE Mark Indication For Its Affera Mapping And Ablation System With Sphere-9 Catheter To Treat Ventricular Arrhythmias, Including Ventricular Tachycardia And Premature Ventricular Complexes
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
Medtronic got permission to sell a heart-treatment device in Europe for more kinds of heart rhythm problems, and the FDA said its new catheter is important and needs faster review. This shows the company is making progress on a medical tool doctors need, which could help its business grow.
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