Irvine, CA – February 8, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced support for two collaborative studies, VIRTUE and POLARIS. These studies aim to better understand the use and workflows with the investigational VARIPULSE™ Platform for treating patients with diverse arrhythmias.
The VIRTUE study is evaluating the use of the investigational VARIPULSE™ Platform in a variety of atrial arrhythmias, including atrial fibrillation (AFib) and atypical atrial flutter (AFL), either as first-time or redo procedures. Spearheaded by Vivek Reddy, M.D., Director of Electrophysiology for the Mount Sinai Health System and The Helmsley Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, the study began in September 2023 and aims to enroll 150 people.
“The VIRTUE study is designed to understand how this Pulsed Field Ablation (PFA) platform can be used to treat a variety of patients,” said Dr. Reddy.ii “The VARIPULSE™ Catheter and it’s integration with CARTO™ holds promise to be a versatile tool for physicians treating many types of patients with atrial arrhythmias.”
A second collaborative study, POLARIS, is evaluating the use and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior left atrial wall ablation, a commonly done ablation lesion set in clinical practice, using the VARIPULSE™ Platform. The study enrolled the first cases in December 2023, and aims to enroll 180 patients with paroxysmal atrial fibrillation (PAF) and 180 patients with persistent atrial fibrillation (Per AF) across four centers in the U.S. The study is led by Moussa Mansour, M.D., Director, Atrial Fibrillation Program; Jeremy Ruskin and Dan Starks Endowed Chair in Cardiology, Massachusetts General Hospital; and Professor of Medicine, Harvard Medical School.
“The POLARIS study includes both paroxysmal and persistent atrial fibrillation patients,” said Dr. Mansour.iii “Results of the study will add to the growing evidence that could point to PFA as the next generation technology for cardiac ablation.”
“Biosense Webster is pleased to collaborate on these studies to further understand the use of the VARIPULSE™ Platform for diverse anatomies and arrhythmia types,” said Jasmina Brooks, President, Biosense Webster. “We are committed to using multiple evidence generation approaches to lead the way in understanding PFA technology to inform future clinical practice.”
AFib is the most common type of cardiac arrhythmia and affects more than six million people in the United States and nearly 38 million people worldwide.1,2 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.3 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.1 Catheter ablation is a safe and effective procedure when drugs don’t work to help restore the heart’s incorrect electrical signals, which causes an abnormal heart rhythm.4
About VIRTUE
The VIRTUE study is a prospective, single-center, non-randomized, interventional clinical study to evaluate the safety and efficacy of using the Biosense Webster, Inc. VARIPULSE™ Platform in a variety of atrial arrhythmias. A total of 150 evaluable subjects will be enrolled including all types of AFib-related arrhythmias.
About POLARIS
The POLARIS study is a prospective, non-randomized, multi-center clinical evaluation to demonstrate safety and effectiveness of PVI and ablation of the left atrial posterior wall using the Biosense Webster, Inc. VARIPULSE™ Platform in comparison to corresponding performance goals. Acute safety data with at least 30 days of follow-up will be assessed. After the study ablation procedure, subjects will enter a 3-month blanking period, followed by a 9-month evaluation period, for a total of 12-months follow-up. Effectiveness will be determined based on incidence of subjects with early onset (within 7 days of ablation procedure) of primary adverse events and the proportion of subjects with freedom from documented atrial fibrillation, atrial tachycardia or AFL.
About VARIPULSE™ Platform
The VARIPULSE™ Platform is Biosense Webster’s Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent PAF using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and VARIPULSE™ Catheter is pending CE mark.
About Biosense Webster
Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTech,i we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
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 VARIPULSE™ Platform clinical trials. 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., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; 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 healthcare products and services; and trends toward healthcare 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 January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. None of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
© Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_THER_303787
Media contact:
Diane Pressman
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Charlene DeBar
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i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii Dr. Reddy is the principal investigator for VIRTUE and was not compensated for his contributions to this announcement.
iii Dr. Mansour is the principal investigator for POLARIS and was not compensated for his contributions to this announcement.
1 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707.
2 Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340
3 Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. doi: 10.1136_bmj.k1453 | BMJ 2018;361:k1453
4 Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072