Biosense Webster enrolls and treats first patient in QDOT AF study

Belgium Hospital Hosts Successful World-first Procedure

Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, a worldwide leader in the diagnosis and treatment of heart arrhythmias, has enrolled and treated the first patient in its QDOT AF Study. The study will evaluate the delivery of high power, short duration ablation with QDOT MICRO, a novel radiofrequency (RF) ablation catheter for the treatment of paroxysmal atrial fibrillation (AF). The first AF patient was treated at OLV Hospital in Aalst, Belgium, one of eight centers in Europe part of the study that will be enrolling up to 50 patients.

AF is fast becoming one of the world’s most significant health issues – affecting 14 million people across Europe, the Middle East and Africa, as well as placing a critical burden on healthcare systems with up to 2.5% of total healthcare expenditure associated with the disease.

QDOT MICRO is a next generation catheter designed to treat AF in a catheter ablation procedure. In what will be a world-first, it delivers 90 watts of RF power in a four-second temperature-controlled catheter ablation session. Its optimized temperature control and micro-electrode technology is designed to provide more efficient and consistent lesion creation with advanced diagnostics, while simplifying the technique and reducing total ablation time.

“The concept of high power short duration ablation is novel and a potentially groundbreaking advancement for the industry,” said Tom De Potter, MD, FEHRA, Associate Director, Cardiovascular Center Department of Cardiology, Electrophysiology Section at OLV Hospital. “The new modality could result in improvements in clinical outcomes and procedural efficiencies and I look forward to further investigation.” Dr De Potter performed the first QDOT MICRO procedure, and is one of the study clinical investigators.

QDOT MICRO, which is only available for investigational use in Europe, is a steerable multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit RF current to the catheter tip electrode for ablation purposes. In addition to force-sensing technology, the catheter incorporates six thermocouple temperature sensors and three micro electrodes embedded in its tip.

“For over 20 years Biosense Webster has pioneered the development of atrial fibrillation treatment” explains Gabriele Fischetto (Vice President of Johnson & Johnson Cardiovascular Specialty Solutions in EMEA). “QDOT MICRO continues our commitment to deliver solutions that help clinicians heal more hearts and has the potential to increase the standard of treatment for paroxysmal atrial fibrillation”.