CAUTION: Investigational device in the U.S. Not available for sale in the U.S. This evidence has not been evaluated by the FDA.

Features

Exclusively integrated with Affera™ mapping and ablation system

 

All-in-one: 
single shot PFA catheter with 8 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.