Biosense Webster has enrolled and treated the first patient in its STELLAR US investigational device exemption (IDE) study. The study will evaluate the safety and effectiveness of Heliostar multi-electrode radiofrequency balloon ablation vatheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation. Up to 640 patients will be enrolled in as many as 40 clinical sites worldwide.
The Heliostar radiofrequency balloon ablation catheter has 10 electrodes, which allows electrophysiologists to deliver different levels of energy depending on the tissue during lesion creation. Additionally, the balloon design makes it possible to achieve pulmonary vein isolation with a single application of radiofrequency energy. The device is compatible with the Biosense Webster CARTO 3 mapping system. A press release reports that the use of the CARTO 3 system during an ablation procedure can reduce exposure to radiation from fluoroscopy.
Andrea Natale (Texas Cardiac Arrhythmia Institute, St David’s Medical Center, Austin, USA), who treated the first patient in the study with Rodney Horton (also Texas Cardiac Arrhythmia Institute, St David’s Medical Center, Austin, USA), says: “The Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and, most importantly, shorter procedure times. Heliostar is an exciting technology and we look forward to seeing the final study results.”
Uri Yaron, worldwide president, Biosense Webster, comments: “The STELLAR study is an important step forward in expanding treatment options for atrial fibrillation patients in the USA. The burden of atrial fibrillation on quality of life, morbidity and mortality is significant and we are committed to developing innovative and life-enhancing technologies that fill important clinical needs, improve care and reduce this burden.”