Late-breaking data on pulmonary vein isolation with Heliostar balloon ablation catheter

balloon catheter graphic

Biosense Webster, Inc. announced that positive results from the company-sponsored STELLAR study were presented as a late breaker, titled "Pulmonary Vein Isolation of Paroxysmal Atrial Fibrillation with Multielectrode Radiofrequency Balloon Catheter: Results from the Global, Multicenter, STELLAR Study," at the 28th Annual International AF Symposium. 

The STELLAR study investigated the safety and efficacy of pulmonary vein isolation (PVI) using the Heliostar balloon ablation catheter in drug refractory symptomatic paroxysmal atrial fibrillation (AF). This study is the largest clinical study to date with 12-month follow-up data for Heliostar balloon ablation catheter.

In the analysis, acute PVI was achieved in 98.8% of subjects, and in 93.0% without additional use of focal catheters. Majority of PVIs were achieved without needing focal touch-up. Primary effectiveness at 12 months was 67.7% and >90% of patients were free from repeat ablation at 12 months. In addition, the rate of clinical success – defined in the study as freedom from 12-month symptomatic atrial arrhythmia recurrence – was 77.7%.1

"With the growing prevalence of AF, it is important that innovative tools are evaluated in various markets and patient populations to deliver value to patients across regions," said Sandeep Goyal, MD, FHRS, director of the electrophysiology lab at Piedmont Atlanta Hospital, who served as an investigator in the STELLAR study. "The results of this study provide further evidence of how RF balloon catheters can be an important tool for electrophysiologists when treating AFib."

The STELLAR Study was an FDA-regulated investigational device exemption study conducted in the U.S., China and Italy to assess the safety and efficacy of PVI using the Heliostar balloon ablation catheter in drug refractory symptomatic paroxysmal AF.

The catheter is the first radiofrequency balloon ablation catheter approved in EMEA for cardiac ablation. It is fully integrated with the CARTO 3 system, enabling an efficient, customizable and reduced fluoroscopy workflow for PVI. HELIOSTAR™ Balloon Ablation Catheter is not approved in the U.S.


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