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BIOSENSE WEBSTER, INC. LAUNCHES STUDY TO EVALUATE NOVEL HIGH POWER, SHORT DURATION MODALITY FOR TREATMENT OF ATRIAL FIBRILLATION

World’s first Procedure at Belgium Hospital

IRVINE, Calif. –MAY 02, 2018– 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 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 successfully at OLV Hospital in Aalst, Belgium, one of eight centers in Europe as part of the study that will enroll up to 50 patients.
An estimated 33 million people worldwide have been diagnosed with AF and its prevalence is projected to increase significantly as the population ages.[1] Approximately 70 percent of patients with AF are between the ages of 65 and 85.[2]

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.+ “This new modality could result in improvements in clinical outcomes and procedural efficiencies and I look forward to further investigation.”

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.

“QDOT MICRO will be a significant advancement in catheter ablation technology that has the potential to elevate the standard of care for atrial fibrillation treatment,” said Shlomi Nachman, Company Group Chair of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “Biosense Webster has a legacy of leadership in cardiac ablation and we are excited by the prospects this new device may provide for millions of patients.”


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, Inc.
Biosense Webster, Inc. 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.

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© Biosense Webster, Inc. 2018

[1] European Heart Journal, Volume 37, Issue 38, 7 October 2016, Pages 2893–2962, https://doi.org/10.1093/eurheartj/ehw210
[2] Amin A, Houmsse A, Ishola A, Tyler J, Houmsse M. The current approach of atrial fibrillation management. Avicenna J Med. 2016 Jan-Mar; 6(1): 8–16.

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    Emma Reynolds
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