IRVINE, Calif., SEPTEMBER 26 – Johnson & Johnson Medical Devices Companies* announced today 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, AL 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 Cardiac Electrophysiology and Cardiovascular Disease, Grandview Medical Center, Birmingham, AL. “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 U.S, 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]
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. Visit www.biosensewebster.com.
About the Johnson & Johnson Medical Devices 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.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the VISITAG SURPOINT Module. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*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.
[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.
