Medtronic presented data at the Heart Rhythm Society Annual Meeting showing that patients treated with the Sphere‑9 catheter for ventricular tachycardia remained free from recurrence 65.5% at six months, supporting the catheter’s safety and efficacy profile.
A sub‑analysis of the Sphere‑360 European study demonstrated 100% lesion durability in patients with left common pulmonary veins, confirming the catheter’s performance across diverse anatomies.
Enrollment began in the Conquer‑AF study, a prospective, multi‑center trial evaluating the Sphere‑9 catheter in patients with recurrent paroxysmal or persistent atrial fibrillation who have previously undergone ablation.
These results reinforce Medtronic’s strategy to expand its Pulsed Field Ablation platform and strengthen its position in the growing atrial fibrillation market. The data support the Affera system’s integrated mapping and dual‑energy (PFA and RF) capabilities, which can improve procedural efficiency and outcomes, potentially driving future revenue growth in the cardiovascular segment.
The Sphere‑9 catheter has received FDA Breakthrough Device Designation for ventricular tachycardia and FDA approval for atrial fibrillation and atrial flutter, while the Sphere‑360 catheter received CE Mark in January 2026 and is enrolling in a U.S. IDE trial. These regulatory milestones, combined with the clinical data, position Medtronic to capture a larger share of the expanding PFA market.
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