Biosense Webster, Inc., a part of Johnson & Johnson MedTech, today announced the European launch of the HELIOSTAR™ Balloon Ablation Catheter – the primary radiofrequency balloon ablation catheter – The HELIOSTAR™ Balloon Ablation Catheter is indicated to be used in catheter-based cardiac electrophysiological mapping (stimulating and recording) of the atria and, when used with a compatible multi-channel RF generator, for cardiac ablation.
Europe is home to greater than 11 million people living with atrial fibrillation (AF); by 2030, the variety of individuals with AF is anticipated to extend by as much as 70%. In Europe, catheter ablation is a beneficial first-line treatment option and is related to a major improvement in quality of life and significant reductions in AF burden and AF-related complications.
The HELIOSTAR™ Balloon Ablation Catheter is fully integrated with the CARTO™ 3 System, a 3D mapping solution. The HELIOSTAR™ Balloon Ablation Catheter has a compliant balloon that may conform to varied pulmonary vein anatomy and provides the flexibility to realize single-shot pulmonary vein isolation (PVI) in 12 seconds.
Use of the HELIOSTAR™ Balloon Ablation Catheter, with the LASSOSTAR™ Catheter and CARTO™ 3 System, may reduce fluoroscopy time and exposure, potentially benefitting each the patient and physician.
Shorter procedure time may require less anesthesia and radiation and will end in less facility time. These time savings may additionally enable more procedures per day, facilitating patient access. HELIOSTAR™ Balloon Ablation Catheter is just not commercially available in the USA.
The HELIOSTAR™ catheter is an efficient and efficient technology, enabling great ends in less procedure time, which has many advantages to each my patients, myself and my staff.
Professor Gian Battista Chierchia, CMO, Electrophysiology Frontiers and Professor of Cardiology, HRMC, Brussels, Belgium
“The high single-shot isolation success rate is especially worthwhile in relation to procedural efficiency, and at my institution, we’ve been in a position to reproducibly perform procedures in 15 – 20 minutes.” Said Professor Gian Battista Chierchia.
The HELIOSTAR™ Balloon Ablation catheter features ten gold-plated, irrigated electrodes, and the quantity of power delivered to every electrode will be customized based on anatomical location and known tissue thickness.
HELIOSTAR™ is the one multi-electrode single-shot balloon with the pliability to perform each circumferential and segmental ablation, enabling personalized PV ablation. The quantity of power delivered to every electrode will be controlled independently and the catheter can deliver titrated radiofrequency energy for a customizable workflow.
The HELIOSTAR™ catheter is an exciting addition to my set of tools for delivering customizable, efficient and effective cardiac ablations. I even have performed greater than 120 cases with this tool at my institution up to now, with a median left atrial procedure time of 35 minutes… As AF prevalence continues to rise and impact more people in Europe and around the globe, I’m all the time searching for novel solutions like this to assist me deliver higher and more personalized treatments for my patients.
Professor Tillman Dahme, Ulm University Medical Center, Department of Medicine II (Cardiology, Angiology, Pneumology, Critical Care Medicine), Germany
In a multicenter single-arm study, SHINE, the HELIOSTAR™ Balloon Ablation Catheter was an efficient treatment for paroxysmal atrial fibrillation (AF) and isolated targeted pulmonary veins (PV) in 98.8% of patients without the necessity for focal touch-up.
The common time to isolation of every pulmonary vein was 9-12 seconds. As well as, the RADIANCE study demonstrated 86% freedom from documented atrial arrhythmia at 12 months. In September 2021, the first post-approval procedures were successfully performed with the HELIOSTAR™ Balloon Ablation Catheter at sites across Europe.
Our goal at Biosense Webster is to utilize the newest science and technology to assist electrophysiologists deliver the perfect possible outcomes for his or her patients… The launch of the HELIOSTAR™ Balloon Ablation Catheter in Europe is an exciting milestone as we work along with the EP community to advance protected, effective and efficient treatment solutions for patients affected by atrial fibrillation.
Michael Bodner, Ph.D., Worldwide President, Biosense Webster
The HELIOSTAR™ Balloon Ablation Catheter is CE Mark approved and now available across Europe. For more information on HELIOSTAR™, visit https://www.jnjmedtech.com/en-EMEA/product/heliostar-balloon-ablation-catheter.
As well as, a Biosense Webster-hosted webinar titled “Clinical Results and Optimized Workflows with the HELIOSTAR™ Balloon Ablation Catheter” is scheduled to happen on Thursday, November 10, 2022, from 5:00 – 6:00pm.
CET. Guest speakers include Prof. Dr. Gian Battista Chierchia, Prof. Dr. Tillman Dahme and Prof. Dr. Boris Schmidt, Cardioangiology Center Bethanien, Frankfurt, Germany. To register, visit: https://cvent.me/Rkzgx0?RefId=Press+Release.