STELLAR IDE Study Begins in United States for Biosense Webster's Heliostar Balloon Ablation Catheter
November 29, 2018—Johnson & Johnson Medical Devices Companies announced that Biosense Webster, Inc. has enrolled and treated the first patient in its STELLAR United States investigational device exemption study. The study will evaluate the safety and effectiveness of the Heliostar multielectrode radiofrequency (RF) balloon ablation catheter 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.
Rodney Horton, MD, treated the first patient in the study with Andrea Natale, MD, at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. Dr. Horton commented in the company's announcement, “This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins.” Dr. Horton is a cardiac electrophysiologist at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.
Dr. Natale added, "The Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters and to 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.” Dr. Natale is a cardiac electrophysiologist and Executive Medical Director at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.
According to the company, the Heliostar RF balloon ablation catheter has 10 electrodes, which allows electrophysiologists to deliver different levels of energy depending on the tissue during lesion creation. In addition, the balloon design makes it possible to achieve pulmonary vein isolation with a single application of RF energy. The device is compatible with the Biosense Webster Carto 3 mapping system, an imaging technology that enables creation of real-time 3D maps of a patient’s cardiac structures. The use of the Carto 3 system during an ablation procedure can reduce exposure to radiation from fluoroscopy, noted the company.