Biosense Webster has announced the European launch of the Heliostar radiofrequency balloon ablation catheter. Heliostar is indicated for use in catheter-based cardiac electrophysiological mapping of the atria and, when used with a compatible multi-channel radiofrequency generator, for cardiac ablation.
The device is fully integrated with the Carto 3 system, a 3D mapping solution and has a compliant balloon that can conform to varied pulmonary vein anatomy and provides the ability to achieve single-shot pulmonary vein isolation (PVI) in 12 seconds.
Use of Heliostar with the Lassostar catheter and Carto 3 system, may reduce fluoroscopy time and exposure potentially benefitting both the patient and physician, Biosense Webster said in a press release. Shorter procedure time may require less anaesthesia and radiation and may result in less facility time.
“The Heliostar catheter is an effective and efficient technology, enabling great results in less procedure time, which has many benefits to both my patients, myself and my staff,” said Gian Battista Chierchia, (HRMC, Brussels, Belgium). “The high single-shot isolation success rate is particularly valuable when it comes to procedural efficiency, and at my institution we have been able to reproducibly perform 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.
“The Heliostar catheter is an exciting addition to my set of tools for delivering customisable, efficient and effective cardiac ablations. I have performed more than 120 cases with this tool at my institution to date, with an average left atrial procedure time of 35 minutes,” said Tillman Dahme (Ulm University Medical Center, Ulm, Germany). “As AF prevalence continues to rise and impact more people in Europe and around the world, I am always looking for novel solutions like this to help me deliver better and more personalized treatments for my patients.”
In a multicentre single-arm study, SHINE, Heliostar was an effective treatment for paroxysmal atrial fibrillation (AF)10 and isolated targeted pulmonary veins (PV) in 98.8% of patients without the need for focal touch-up. Average time to isolation of each pulmonary vein was 9‒12 seconds. In addition, 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.