Biosense Webster Launches RF Balloon Ablation Catheter in Europe

Biosense Webster, part of Johnson & Johnson MedTech, has launched the HELIOSTAR Balloon Ablation Catheter in Europe – a radiofrequency balloon ablation catheter.

The HELIOSTAR 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 HELIOSTAR Balloon Ablation Catheter is fully integrated with the CARTO 3 system, a 3D mapping solution. The HELIOSTAR 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, together 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. The HELIOSTAR Balloon Ablation Catheter is not commercially available in the United States.

Professor Gian Battista Chierchia, Full Professor of Cardiology, HRMC, Brussels, Belgium, CMO Electrophysiology Frontiers, said: “The HELIOSTAR catheter is an effective and efficient technology, achieving excellent results in less procedure time, which has many benefits for my patients, myself and my staff. The high success rate of single-shot isolation is especially valuable when it comes to procedural efficiency, and at my facility we have been able to perform reproducible procedures in 15-20 minutes.

The HELIOSTAR 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-shot 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 independently controlled, and the catheter can deliver titrated radiofrequency energy for a customizable workflow.

Professor Tillman Dahme, University Medical Center Ulm – Department of Medicine II (Cardiology, Angiology, Pulmonology, Critical Care Medicine), Germany, said: “The HELIOSTAR catheter is a great addition to my tool set to provide customizable and effective solutions. , and effective 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 people in Europe and around the world, I am always looking for new solutions like this to help me provide better treatments. and more personalized to my patients. »

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 the need for focal retouch. 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.

Michael Bodner, Ph.D., Global President of Biosense Webster, said, “Our goal at Biosense Webster is to use the latest advancements in science and technology to help electrophysiologists deliver 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 advance safe, effective and efficient treatment solutions for patients with atrial fibrillation.