J&J Subsidiary Launches IDE Study for AF

The study will evaluate Biosense Webster's Heliostar radiofrequency balloon ablation catheter for the treatment of symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.

The Heliostar RF balloon ablation catheter has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and shorter procedure times, according to cardiac electrophysiologist Andrea Natale, MD, the executive medical director at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center.

Biosense Webster Inc.

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 pulmonary vein isolation with a single application of RF energy. The device is compatible with the Biosense Webster Carto 3 mapping system, an advanced imaging technology that enables the creation of real-time 3D maps of a patient's cardiac structures.

The potential market size of the Heliostar is significant. The company noted that about 33 million people worldwide have AF.

"The STELLAR study is an important step forward in expanding treatment options for atrial fibrillation patients in the United States," said Uri Yaron, worldwide president at Biosense Webster. "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."

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