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Published data from the Journal of American College of Cardiology: Clinical Electrophysiology showcased at the 15th edition of Venice Arrhythmias 2017

BRUSSELS, Nov. 22, 2017 /PRNewswire/ -- Biosense Webster, a Division of Johnson & Johnson Medical NV/SA, and a leader in the diagnosis and treatment of cardiac arrhythmias, recently presented new data evaluating the one-year outcomes of atrial fibrillation (AF) ablation using the CARTO^® 3 System CARTO VISITAG^™ Module with Ablation Index at Venice Arrhythmias 2017. Patients were followed for a year and monitored for instances of atrial fibrillation, atrial flutter and atrial tachycardia via Holter electrocardiographs at 3, 6 and 12 months.

The results, published in the Journal of American College of Cardiology: Clinical Electrophysiology, show that after 12 months, 92.3% of patients (n=130) were free from arrhythmia (atrial fibrillation, atrial flutter and atrial tachycardia).¹

Atrial fibrillation affects around 14 million people across Europe, the Middle East and Africa² – with patients suffering from this condition said to have an increased risk of mortality and a five-fold increased risk of having a stroke³.  "Atrial fibrillation is the new epidemic of modern society; both underdiagnosed and poorly treated," said Gabriele Fischetto, Vice President of Johnson & Johnson Cardiovascular Specialty Solutions in EMEA. "With a 21-year legacy of expertise in electrophysiology, our mission at Biosense Webster is to deliver breakthrough innovations that help restore a patient's regular heart rhythm and quality of life.  This new evidence gives us a strong indication that we are making great strides in helping to cure this debilitating disease."

Biosense Webster's CARTO^® 3 System is an advanced imaging system that uses electromagnetic technology to create real-time 3D maps of a patient's cardiac structures. The addition of the CARTO VISITAG™ Module with Ablation Index provides a visual indication based on the integration of stability, power, contact force and time parameters to be displayed on the CARTO^® 3 System. This index was developed to simplify and standardize the workflow for ablating patients with paroxysmal atrial fibrillation (PAF) and support electrophysiologists using the CARTO SMARTTOUCH™ Technology, in reproducing their own successful ablation strategy to achieve Pulmonary Vein Isolation.

The author of the study, Prof. M. Duytschaever, MD, Heart Division Az Sint-Jan Hospital, Belgium, commented: "With the increased risk of morbidity and mortality, it is vital that physicians have access to effective treatments for AF. The results published in this paper clearly demonstrate the important role of a reproducible workflow for PAF and of the CARTO^® 3 System CARTO VISITAG^™ with Ablation Index. This single-procedure solution not only offers a >90%¹ success rate after one year, but the technology has also improved my procedure efficiency by reducing operating time by almost 30% and radiofrequency ablation time by almost 40%."

Important Information: The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. Refer to the CARTO® 3 System Instructions For Use (IFU) for indications, contraindications, side effects, suggested procedure, warnings and precautions as well proper recommendations and settings.

The Ablation Index should not be used to replace standard handling precautions or other clinically accepted endpoints for RF applications such as reduction of IC signals, impedance drop, temperature, force, etc.

About Biosense Webster's CARTO^® 3 System
The CARTO^® 3 System is an advanced imaging technology that utilizes electromagnetic technology to create real-time 3D maps of a patient's cardiac structures. The system is designed to help electrophysiologists navigate the heart by generating an accurate 3D map, as well as pinpointing the exact location and orientation of catheters in the heart during catheter ablation procedures for patients suffering from heart rhythm conditions (cardiac arrhythmias). During catheter ablation, doctors insert a therapeutic catheter through a small incision in the groin where it is then weaved up to the heart through a blood vessel. Once it reaches the left upper chamber of the heart (atrium), radiofrequency energy is delivered to the heart wall to create lesions that block faulty electrical impulses that can cause heart rhythm disorders.

About Biosense Webster
Biosense Webster, a division of Johnson & Johnson Medical NV/SA, 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. With a 21-year legacy of expertise in electrophysiology, Biosense Webster's mission is to deliver breakthrough innovations that help restore a patient's regular heart rhythm. More information can be found at www.biosensewebster.com.

References

¹ 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)
² Data extracted by Global Burden Disease (GBD) Results Tool- GHDx website 24/10/2017
³ Wolf et al 1991 Atrial Fibrillation as an Independent Risk Factor of Stroke: The Framingham Study, Journal of the American Heart Association, Vol 22, Pages 983 - 988

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