Biosense Webster,part of Johnson & Johnson MedTech, announced the European launch of the Heliostar Balloon Ablation Catheter, the first radiofrequency balloon ablation catheter.
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The Heliostar Balloon Ablation Catheter is indicated for use 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.
In Europe, catheter ablation is a recommended first-line treatment option‡4 and is associated with a significant 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 can conform to varied pulmonary vein anatomy and provides the ability to achieve 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 both the patient and physician.
Shorter procedure time may require less anesthesia and radiation and may result in less facility time. These time savings may also enable more procedures per day, facilitating patient access. The Heliostar Balloon Ablation Catheter is not commercially available in the United States.
The Heliostarâ„¢ 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 controlled independently and the catheter can deliver titrated radiofrequency energy for a customizable workflow.
In a multicenter single-arm study, SHINE, the Heliostar Balloon Ablation Catheter 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.
The Heliostar Balloon Ablation Catheter is CE Mark approved and now available across Europe. ■