Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said this week that it enrolled and treated the first patient in its Stellar U.S. investigational device exemption study.
The 640-patient trial is designed to assess the safety and efficacy of the Heliostar multi-electrode radiofrequency balloon ablation catheter as a treatment for drug refractory recurrent paroxysmal atrial fibrillation.
The Heliostar device features 10 electrodes and is designed to allow electrophysiologists to achieve pulmonary vein isolation with a single application of RF energy, according to Biosense Webster.
Cardiac electrophysiologists Drs. Rodney Horton and Andrea Natale treated the first patient in the Stellar study at the Texas Cardiac Arrhythmia Institute.
“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 said in prepared remarks.
“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,” Dr. Natale added.
“The Stellar study is an important step forward in expanding treatment options for atrial fibrillation patients in the United States,” Uri Yaron, worldwide president of Biosense Webster, said. “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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