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

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

Biosense Webster, Inc., part of Johnson & Johnson MedTech, today announced the European launch of the HELIOSTAR™ Balloon Ablation Catheter – the first radiofrequency balloon ablation catheter. The HELIOSTAR™ Balloon Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulation and recording) of the atria and, when used with a compatible multichannel RF generator, for cardiac ablation.

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

The HELIOSTAR™ Balloon Ablation Catheter is fully integrated into the CARTO™ 3 System, a 3D mapping solution. The HELIOSTAR™ Balloon Ablation Catheter features a compliant balloon that can adapt to varying pulmonary vein anatomy, providing the ability to 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, potentially benefiting both the patient and physician.

A shorter procedure time may require less anesthesia and radiation and may result in a shorter setup time. This time saving also potentially allows for more procedures per day, thereby facilitating patient access. The HELIOSTAR™ Balloon Ablation Catheter is not commercially available in the United States.

The HELIOSTAR™ catheter is an effective and efficient technology that enables great results in less procedure time, which has many benefits for my patients as well as 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 particularly valuable when it comes to procedural efficiency, and at my institution we were able to reproducibly perform procedures in 15 to 20 minutes.” Said Professor Gian Battista Chierchia.

The HELIOSTAR™ Balloon Ablation Catheter features ten gold-plated, irrigated electrodes, and the amount of energy delivered to each electrode can be individually adjusted depending on anatomical location and known tissue thickness.

HELIOSTAR™ is the only multi-electrode, single-shot balloon with the flexibility to perform both circumferential and segmental ablation, enabling personalized PV ablation. The amount of energy 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 toolkit for performing customizable, efficient and effective cardiac ablations. To date, I have performed more than 120 cases in my institution using this tool, with the average procedure time in the left atrium being 35 minutes... As the prevalence of atrial fibrillation continues to increase and affect more and more people in Europe and around the world, I am always looking for novel solutions like this to help me offer better and more personalized treatments for my patients.

Professor Tillman Dahme, Ulm University Hospital, Department of Internal Medicine II (Cardiology, Angiology, Pulmonology, Intensive Care Medicine), Germany

In a multicenter, single-arm 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 the need for focal retreatment.

The average time to isolate each pulmonary vein was 9–12 seconds. Additionally, the RADIANCE trial showed that at 12 months, 86% had no documented atrial arrhythmias. In September 2021 the first post-approval process have been successfully performed using the HELIOSTAR™ balloon ablation catheter at locations across Europe.

At Biosense Webster, our goal is to leverage the latest science and technology to help electrophysiologists achieve the best possible outcomes for their patients... The launch of the HELIOSTAR™ Balloon Ablation Catheter in Europe is an exciting milestone as we work with the EP community to provide safe, effective and efficient treatment solutions for patients with atrial fibrillation to move forward.

Michael Bodner, Ph.D., worldwide president, Biosense Webster

The HELIOSTAR™ Balloon Ablation Catheter is CE approved and now available across Europe. Further information about HELIOSTAR™ can be found at https://www.jnjmedtech.com/en-EMEA/product/heliostar-balloon-ablation-catheter.

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

CET. The guest speakers include Prof. Dr. Gian Battista Chierchia, Prof. Dr. Tillman Dahme and Prof. Dr. Boris Schmidt, Bethanien Cardioangiological Center, Frankfurt, Germany. To register, visit: https://cvent.me/Rkzgx0?RefId=Press+Release.

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