CAUTION: The use of the Sphere-9™ catheter for VT ablation and the associated software are investigational in the U.S. This evidence has not been evaluated by FDA.

Features

Exclusively integrated with Affera™ mapping and ablation system

All-in-one: mapping, radiofrequency (RF) and pulsed field ablation (PFA) catheter

Wide-area focal ablation catheter

Tissue-conformable lattice tip 

Pulsed field mapping to verify VT ablation targets at critical locations

Purpose and design

The Sphere-9™ Ventricular Tachycardia Early Feasibility Study (EFS) is a prospective, multicenter, nonrandomized feasibility study designed to evaluate the safety and performance of the Sphere-9™ catheter integrated with the Affera™ mapping and ablation system. The study evaluates investigational RF and PFA therapy settings for the treatment of recurrent, sustained, scar-related monomorphic VT. The study was initiated to include patients with ischemic cardiomyopathy only, and enrollment began in March 2025. The trial was expanded to included nonischemic cardiomyopathy patients in 2026. A U.S. pivotal trial (Sphere VT) was approved to begin enrollment in April 2026.

Learn more about the studies.

Trial results

VT ablation clinical outcomes1,2

The study is a prospective EFS designed to evaluate the safety and performance of the Affera™ ablation system using the Sphere‑9™ catheter for the treatment of monomorphic VT due to prior myocardial infarction.

100%

primary
effectiveness

Acute noninducibility of the
clinically relevant VT (N = 40)

Six-month outcomes†

0

burden
post-ablation

Median device detected VT episodes
per month post-ablation (N = 20)

65.5%

freedom from
any sustained
monomorphic VT

Interim Kaplan-Meier estimate;
follow-up ongoing for 20/40 patients

† N = device-related safety events reported in 2/40 patients.