Biosense Webster, part of the Johnson & Johnson Medical Devices Companies has announced post-approval procedures were successfully performed with the Heliostar radiofrequency balloon ablation catheter at sites across Europe. In Europe, the Heliostar Balloon Catheter is indicated for use in catheter-based cardiac electrophysiological mapping of the atria and for cardiac ablation.
The device, with the Lassostar catheter and Carto 3 System, allows physicians to provide more efficient ablation procedures, with lower procedure times and reduced fluoroscopy time and exposure, Biosense Webster says in a press release, potentially benefitting both the patient and physician. Shorter procedure time may require less anaesthesia and radiation and may result in less nursing and facility time. These time savings may also enable more procedures per day facilitating patient access.
The novel Heliostar balloon ablation catheter features ten gold-plated, irrigated electrodes that can be tailored based on anatomical location and known tissue thickness enabling personalised ablation procedures for unique patient anatomies and arrhythmias. The amount of power delivered to each electrode can be controlled independently to provide electrophysiologists with greater customisation, control and the ability to achieve pulmonary vein (PV) isolation in approximately ten seconds, Biosense Webster’s press release adds.
“Pulmonary vein isolation is a technically complex and time-consuming procedure so it is important that advancements in balloon ablation systems help electrophysiologists quickly and easily isolate the pulmonary veins, while maintaining safety,” said Ahmed Abdelaal, senior R&D director and Heliostar project leader at Biosense Webster. “The Heliostar balloon ablation catheter was developed with electrophysiologists in mind giving them the ability to perform personalised ablation procedures to better meet patient’s needs.”
In a multicentre single-arm study, SHINE, the Heliostar balloon ablation catheter was an effective treatment for paroxysmal atrial fibrillation (AF) and electrophysiologists isolated targeted pulmonary veins (PV) in 98.8% of patients without the need for focal touch-up. On average, time to isolation of the pulmonary vein was approximately ten seconds, total procedure time was less than 90 minutes and dwell time was less than 40 minutes.
“Heliostar balloon ablation catheter reaffirms our commitment to partnering with physicians to advance the practice of electrophysiology and to help change the lives of patients suffering from atrial fibrillation,” said Uri Yaron, Worldwide President of Biosense Webster. “With CE mark approval and the first commercial procedures completed, we have made significant progress in providing electrophysiologists with another novel option for the safe and efficient treatment of this burdensome disease.”
In Europe, full commercial availability is expected in 2022. In the USA, Heliostar is an investigational device and is not approved by the US Food & Drug Administration (FDA).