Medtronic reports interim Sphere-9 VT data and receives FDA breakthrough designation
Medtronic reported interim Affera Sphere-9 data showing 65.5% of VT patients were free from recurrence at six months. The FDA granted Breakthrough Device designation for Sphere-9 and approved a U.S. pivotal IDE.
Medtronic reported interim clinical and regulatory milestones for the Affera system and Sphere-9 and Sphere-360 catheters on April 25, 2026. In the ongoing early feasibility study, 65.5% of VT patients were free from recurrence at six months, and the FDA granted Breakthrough Device designation for Sphere-9 and approved a U.S. pivotal IDE.
Results from the ongoing early feasibility study are evaluating the Affera mapping and ablation system and the Sphere-9 catheter for treatment of recurrent sustained monomorphic ventricular tachycardia after a heart attack. Interim results were presented as a late-breaking clinical trial.
The company said Sphere-9 is not approved for VT in any geography. It also said the first patients were enrolled in the Conquer-AF trial to evaluate the Sphere-9 catheter for repeat atrial fibrillation procedures.
For Sphere-360, the company reported 100% lesion durability in left common pulmonary veins in a subanalysis. Sphere-360 received CE Mark in January 2026, and a U.S. IDE is enrolling.