IDE Study Begins for Biosense Webster's QDot Micro RF Ablation Catheter
February 8, 2019—Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, has enrolled and treated the first patient in its United States investigational device exemption (IDE) study evaluating the company’s QDot Micro radiofrequency (RF) ablation catheter for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The study will enroll up to 185 patients at up to 30 centers in the United States.
According to the company, the QDot Micro RF ablation catheter delivers 90 watts of RF power in a short, 4-second, temperature-controlled session. The device's temperature-control and microelectrode technology are specifically designed to provide more efficient and consistent lesion creation with advanced diagnostics. The QDot Micro RF ablation catheter is only available for investigational use in the United States.
The first AF patient was treated by electrophysiologist Larry A. Chinitz, MD, at New York University Langone Health’s Heart Rhythm Center in New York, New York. In the company's announcement, Dr. Chinitz commented, “The delivery of 90 watts of RF power in a short, 4-second ablation session is a significant advancement in the treatment of paroxysmal AF. We’re eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes.”