J & amp;J Subsidiary Launches IDE Study for AF

A new U.S. study aims to evaluate a radiofrequency (RF) balloon ablation catheter for the treatment of symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation. Biosense Webster, a subsidiary of Johnson & Johnson, said the investigational device exemption study will enroll up to 640 patients at as many as 40 clinical sites worldwide. The STELLAR study will evaluate the company's Heliostar RF balloon ablation catheter. "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," said cardiac electrophysiologist Rodney Horton, MD, who treated the first patient in the study with Andrea Natale, MD, at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center. Natale, a cardiac electrophysiologist and the executive medical director at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center, said the Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and shorter procedure times. The new device 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 ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news