WASHINGTON (dpa-AFX) - Thursday, Medtronic plc (MDT) announced the expansion of the CE Mark indication for the Affera Mapping and Ablation System with Sphere-9 Catheter to treat ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes.
The company stated that the expansion reflects its efforts to broaden the footprint of Affera technology among more physicians and patients.
Also, the U.S. Food and Drug Administration has granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias.
Currently, 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.
In the pre-market hours, Medtronic's stock is trading at $85.21, down 0.90 percent on the NYSE.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
