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; AF burden measured for three 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 fluoro, 26 patients with less than or equal to 3 minutes of fluoro.

New analysis presented at HRS 2026

Capabilities of the Sphere-360™ PFA catheter to treat patients with left common pulmonary veins (LCPVs)2

A new analysis of the Sphere-360™ European Study reports results for the subset of PAF patients with diverse PV anatomy undergoing PVI with the Sphere-360™ PFA platform and PULSE3 optimized waveform (N = 8).

7.1 ± 1.5

applications per LCPV

3.7 ± 2.6 min

average LCPV ablation time

100%

durability of LCPVs

PFA lesion durability
demonstrated by invasive remapping
75 ± 15 days post-ablation