First Atrial Fibrillation Patient Treated In Biosense Webster U.S. IDE Study Evaluating High Power, Short Duration Ablation Catheter
IRVINE, Calif., Feb. 4, 2019 — Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study which evaluates the company's QDOT MICRO Radiofrequency (RF) Ablation Catheter used for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The first AF patient was treated at NYU Langone Health's Heart Rhythm Center in New York City, one of up to 30 centers participating in the study that will enroll up to 185 patients throughout the U.S.
"The delivery of 90 watts of RF power in a short, four-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibrillation," said Dr. Larry A. Chinitz, electrophysiologist and Director of the Heart Rhythm Center at NYU Langone Health, who treated the first patient in the study. "We're eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes."
Current catheter technologies typically deliver RF ablation at an average power level between 20 and 40 watts and for a duration of 20 to 40 seconds. The QDOT MICRO RF Ablation Catheter, which is only available for investigational use in the United States, is the first to deliver 90 watts of RF power in a short, four-second temperature-controlled session. Its temperature control and micro-electrode technology is specifically designed to provide more efficient and consistent lesion creation with advanced diagnostics.
An estimated 33 million people worldwide have been diagnosed with AF and its prevalence is projected to increase significantly as the population ages. Approximately 70 percent of patients with AF are between the ages of 65 and 85.
"The QDOT MICRO RF Ablation Catheter is an example of the innovations we've been focused on developing to elevate the standard of care for patients with Cardiac Arrhythmias," said Uri Yaron, Worldwide President of Biosense Webster, Inc. "We believe this ablation catheter will revolutionize the field of ablation and hope it will make a meaningful difference in outcomes for both physicians and patients, just as the first catheter created by our co-founder, the late Will Webster, did."
The QDOT MICRO IDE follows the commencement of the STELLAR U.S. IDE study in November which will evaluate the safety and effectiveness of the HELIOSTAR Multi-electrode Radiofrequency Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.
About Johnson & Johnson Medical Devices Companies
As the world's most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we're working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.
About Biosense Webster, Inc.
Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit www.biosensewebster.com.