Johnson & Johnson Medical Devices Companies* announced that Biosense Webster Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has received approval from the U.S. Food and Drug Administration (FDA) for its VISITAG SURPOINT External Processing Unit and enrollment has begun in its post-market approval study.
 
The VISITAG SURPOINT Module calculates a Tag Index, a single value combining parameters of power, contact force and duration during a catheter ablation procedure. The index was developed to simplify and standardize the workflow for ablating patients with paroxysmal atrial fibrillation (PAF) and to support electrophysiologists using the CARTO SMARTTOUCH Technology, to achieve Pulmonary Vein Isolation (PVI).
 
Dr. Jose Osorio** at Grandview Medical Center in Birmingham, Ala., recently enrolled and treated the first patients in a post-market approval study that is assessing Tag Index-guided ablation using the VISITAG SURPOINT Module.
 
“We’re always looking for ways to improve procedure efficiency and are proud to be early adopters of this innovative technology,” said Dr Osorio, board-certified in Cardiac Electrophysiology and Cardiovascular Disease at Grandview Medical Center in Birmingham. “I look forward to integrating the prescriptive Tag-Index guided ablation into my workflow for PVI.”
 
Over 30,000 patients have been treated with the technology outside the United States, where it is commercialized as CARTO 3 System CARTO VISITAG Module with Ablation Index.
 
"Biosense Webster is committed to developing technologies, techniques and tools that optimize procedures and advance the treatment of atrial fibrillation,” said Celine Martin, worldwide president of Biosense Webster Inc. “Beginning commercialization of the VISITAG SURPOINT Module in the U.S is a major milestone.” 
 
An estimated 33 million people worldwide have been diagnosed with atrial fibrillation and its prevalence is projected to increase significantly as the population ages.¹ Approximately 70 percent of patients with atrial fibrillation are between the ages of 65 and 85.² 
 
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.

The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
 
*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
 
** Consultant to Biosense Webster Inc.

References
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.