Biosense Webster Launches Study to Evaluate Novel High Power, Short Duration Modality for Treatment of Atrial Fibrillation

PUBLISHED: 09 May 2018

Biosense Webster Launches Study to Evaluate Novel High Power, Short Duration Modality for Treatment of Atrial Fibrillation
Belgium Hospital Hosts Successful World-first Procedure

Brussels, Belgium – May 09 2018 – 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 Africai, as well as placing a critical burden on healthcare systems with up to 2.5% of total healthcare expenditure associated with the disease².

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”.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies* have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

About Biosense Webster

Biosense Webster 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. Biosense Webster, Inc. is part of the Johnson & Johnson Family of Companies. More information can be found at www.biosensewebster.com.

*Comprising the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

**QDOT AF Study (Atrial Fibrillation Ablation Delivering higher power in a Shorter amount of Time Study) Clinical Study for Safety and Acute Performance Evaluation of the QDOT MICRO Catheter used with Fast Ablation Mode in Treatment of Patients with Paroxysmal Atrial Fibrillation.

QDOT MICRO is exclusively for clinical investigations use only and is not commercially available anywhere in the world. ClinicalTrials.gov Identifier: NCT03459196

+Dr. De Potter performed the first QDOT MICRO procedure and is one of the study clinical investigators.

Reference

Taghji, P. et al. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation, Journal of American College of Cardiology: Clinical Electrophysiology, article in press (2017)2Ball et al. Atrial Fibrillation: Profile and burden of an evolving epidemic in the 21st Century. International Journal of Cardiology 167 (2013) 1807 – 1824