Biosense Webster launches HELIOSTAR™ in Europe, the first radiofrequency balloon ablation catheter, enabling physicians to perform more efficient cardiac ablations

Biosense Webster, Inc., a subsidiary of Johnson & Johnson MedTech, today announced the European launch of HELIOSTARBalloon Ablation Catheter – The First Radio Frequency Balloon Ablation Catheter – THE HELIOSTAR The Balloon Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (pacing and recording) of the atria and, when used with a compatible multi-channel RF generator, for cardiac ablation.

Europe has more than 11 million people with atrial fibrillation (AF); by 2030, the number of people with AF is expected to increase by up to 70%. In Europe, catheter ablation is a recommended first-line treatment option and is associated with significant improvement in quality of life and significant reductions in the burden of AF and AF-related complications.

THE HELIOSTARThe balloon ablation catheter is fully integrated into the CARTO3 System, a 3D mapping solution. THE HELIOSTAR The Balloon Ablation Catheter features a conformal balloon that can accommodate varied pulmonary vein anatomy and achieve one-shot pulmonary vein isolation (PVI) in 12 seconds.

Using the HELIOSTAR Balloon ablation catheter, with the LASSOSTAR Catheter and CARTO 3 System, can reduce fluoroscopy time and exposure, which can benefit both patient and physician.

A shorter procedure time may require less anesthesia and radiation therapy and may result in reduced installation time. These time savings can also allow for more procedures per day, making it easier for patients to access. HELIOSTAR The balloon ablation catheter is not commercially available in the United States.

THE HELIOSTARThe catheter is an effective and efficient technology, allowing excellent results in less procedure time, which has many advantages for my patients, myself and my staff.

Professor Gian Battista Chierchia, CMO, Electrophysiology Frontiers and Professor of Cardiology, HRMC, Brussels, Belgium

“The high success rate of single-shot isolation is especially valuable when it comes to procedural efficiency, and at my facility, we were able to perform procedures reproducibly in 15 to 20 minutes.” Said Professor Gian Battista Chierchia.

THE HELIOSTAR The balloon ablation catheter features ten gold-plated irrigated electrodes, and the amount of power delivered to each electrode can be customized based on anatomical location and known tissue thickness.

HELIOSTAR is the only multi-electrode single injection balloon with the flexibility to perform both circumferential and segmental ablation, enabling personalized PV ablation. The amount of power delivered to each electrode can be controlled independently and the catheter can deliver titrated radiofrequency energy for a customizable workflow.

THE HELIOSTAR catheter is an exciting addition to my toolset for performing customizable, effective and efficient cardiac ablations. I have performed over 120 cases with this tool at my facility to date, with an average left atrial procedure time of 35 minutes…As the prevalence of AF continues to rise and affect more and more more people in Europe and around the world, I’m always looking for new solutions like this to help me deliver better and more personalized treatments to my patients.

Professor Tillman Dahme, University Medical Center Ulm, Department of Medicine II (Cardiology, Angiology, Pulmonology, Critical Care Medicine), Germany

In a single-arm, multicenter study, SHINE, the HELIOSTAR Balloon ablation catheter was an effective treatment for paroxysmal atrial fibrillation (AF) and isolated targeted pulmonary veins (PV) in 98.8% of patients without requiring focal retouching.

The average isolation time for each pulmonary vein was 9 to 12 seconds. In addition, the RADIANCE study demonstrated an 86% freedom from documented atrial arrhythmia at 12 months. In September 2021, the first post-approval procedures have been successfully performed with the HELIOSTAR™ Balloon Ablation Catheter at sites across Europe.

Our goal at Biosense Webster is to use the latest science and technology to help electrophysiologists deliver the best possible results to their patients… The Launch of HELIOSTARThe balloon ablation catheter in Europe is an exciting milestone as we work with the EP community to advance safe, effective and efficient treatment solutions for patients with atrial fibrillation.

Michael Bodner, Ph.D., Global President, Biosense Webster

THE HELIOSTARThe Balloon Ablation Catheter is CE approved and now available throughout Europe. For more information on HELIOSTARvisit https://www.jnjmedtech.com/en-EMEA/product/heliostar-balloon-ablation-catheter.

Additionally, a webinar hosted by Biosense Webster titled “Optimized Clinical Outcomes and Workflows with the HELIOSTARBalloon Ablation Catheter” is scheduled for Thursday, November 10, 2022, from 5:00 p.m. to 6:00 p.m.

HEC. Guest speakers include Prof. Dr. Gian Battista Chierchia, Prof. Dr. Tillman Dahme and Prof. Dr. Boris Schmidt, Cardiangiology Center Bethanien, Frankfurt, Germany. To register, go to: https://cvent.me/Rkzgx0?RefId=Press+Release.