Sphere-360™ Ablation Catheter Clinical Evidence | Medtronic (Europe)

Sphere-360™ catheter received CE Mark

Features

Exclusively integrated with Affera™ mapping and ablation system

All-in-one:
single-shot PFA catheter with 10 Fr shaft

Tissue-conformable lattice tip

Rotation-free ablation

Adjustable shape:
fully expandable to 34 mm

Study purpose and design

The Sphere-360™ European study was a prospective, single-arm, multicenter trial designed to evaluate safety, effectiveness, and lesion durability of the Sphere-360™ catheter when used for the treatment of symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients (n = 100). Results of this study are outlined in the manuscript ”One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation” linked below.

Learn more about the study.

Read the manuscript (open in new window)

Trial results¹

This study was a prospective, single-arm trial evaluating the safety, efficacy, and durability of the Sphere-360™ PFA catheter for the treatment of PAF.

Efficacy outcomes

Freedom from AF/AT/AFL

AA burden with continuous monitoring for recurrent patients^†

Daily AA burden (%)

PV durability^‡

PFA lesion durability demonstrated by invasive remapping 75 days post-ablation

Safety outcomes

0

primary adverse events^§

Applications per PV

4.0 ± 1.3

applications per PV

Average procedure time^◊

58 min

procedure time^¶

22 min

LA dwell time

< 12 min

PV transpired time

< 7 min

fluoroscopy time^#

PVI: Pulmonary vein isolation; AF: Atrial fibrillation; AT: Atrial tachycardia; AFL: Atrial flutter; AA: Atrial arrhythmia; PV: Pulmonary vein; LA: Left atrial.

† N = 15 patients monitored with ILR in PULSE3 cohort; and AF burden measured for 3 recurrent patients.

‡ Fifty patients treated with the PULSE3 optimized and most recent waveform configuration, 40 of which completed the optional remapping procedure.

§ See manuscript for all adverse event incidence.

◊ See manuscript for full listing of procedural characteristics.

¶ Includes 20-minute wait time.

# Four patients done with 0 fluoroscopy workflow, 26 patients with less than or equal to 3 minutes of fluoroscopy.

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Please note that the intended use of a product may vary depending on geographical approvals.

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Reddy VY, Peichl P, Kautzner J, et al. One-year outcomes of a conformable single-shot pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation. Heart Rhythm. 2025: S1547-5271(25)02379-3. doi.org/10.1016/j.hrthm.2025.04.031.

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