Medtronic announces milestones for Sphere-9, Sphere 360 catheters

Medtronic (MDT) announced continued momentum for the Affera family of technologies for cardiac arrhythmia treatment, including promising data presented at the Heart Rhythm Society, HRS, Annual Meeting and the start of a new trial to evaluate a broader population of atrial fibrillation, Afib, patients. Results from the ongoing early feasibility study evaluating the Affera mapping and ablation system and the Sphere-9 catheter for treatment of recurrent sustained monomorphic ventricular tachycardia after a heart attack were presented as a late-breaking clinical trial. Patients treated at centers across the U.S. were followed for six months post-ablation. Results showed 65.5% of patients remaining free from VT recurrence at six months. The U.S. Food and Drug Administration granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of VT, providing an expedited regulatory pathway for the technology. At HRS, a new sub-analysis from the Sphere-360 European study demonstrated positive results related to durability of lesions in AFib procedures in patients with left common pulmonary veins. Results showed 100% lesion durability, highlighting consistency across patients with varied anatomies. Medtronic also announced the first patient enrollment in Conquer-AF, a prospective, multi-center, interventional, non-randomized study to characterize the safety and effectiveness of the Sphere-9 catheter in patients with recurrent paroxysmal or persistent AFib who have previously had an ablation procedure.