Biosense Webster Supports Collaborative Studies That Aim to Expand Knowledge in Pulsed Field Ablation

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced the 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. “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. “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. Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib. Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression. 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.