The expansion allows physicians to utilize the Sphere-9 technology for conditions originating in the heart's lower chambers, a significant move for a market that has seen little innovation in ablation tools despite the high risks associated with these heart rhythm disorders. Rebecca Seidel, president of Electrophysiology Therapies at Medtronic, noted that this milestone provides a fast-growing opportunity to deploy the system's versatility and safety profile to a broader patient demographic.
Medtronic expands CE Mark for Affera system to treat ventricular arrhythmias
Medtronic has secured an expanded CE Mark for its Affera Mapping and Ablation System, specifically the Sphere-9 catheter, to treat ventricular arrhythmias. This regulatory approval positions the device as the first all-in-one, large-tip focal catheter capable of both mapping and dual-energy ablation for ventricular tachycardia and premature ventricular complexes.
Beyond the European market, the U.S. Food and Drug Administration has granted the Sphere-9 catheter Breakthrough Device Designation, streamlining the regulatory pathway for potential approval in the United States. Enrollment is currently active for the Sphere VT pivotal trial, which aims to generate clinical evidence for the system's efficacy in treating ventricular tachycardia. Dr. Khaldoun Tarakji, chief medical officer for the company’s Cardiac Ablation Solutions, emphasized that the catheter's ability to switch between pulsed field and radiofrequency energy addresses long-standing challenges in treating complex arrhythmias.
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