Biosense Webster today announced its support for two collaborative studies using its Varipulse pulsed field ablation (PFA) platform.
Johnson & Johnson MedTech’s electrophysiology unit says the two collaborative studies aim to better understand the use and workflows of the investigational platform in treating diverse arrhythmias.
Varipulse features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. This platform holds approval in Japan, while it remains unavailable for sale in the EU and U.S.
Earlier this week, Biosense Webster shared positive one-year results from multiple studies evaluating Varipulse. Both studies demonstrated significant freedom from AFib recurrence.
Pulsed field ablation is one of the hottest spaces in medtech. Biosense Webster hopes to use Varipulse to establish itself among fierce competition. Boston Scientific won FDA approval for its Farapulse system last week. That came shortly after Medtronic won the first FDA nod for PFA to treat paroxysmal and persistent AFib.
About the Varipulse studies supported by Biosense Webster
The VIRTUE study looks at Varipulse in a variety of arrhythmias, including AFib and atypical atrial flutter. It evaluates the system in first-time or redo procedures. Dr. Vivek Reddy of Mount Sinai spearheads the study, which began in September 2023 and aims to enroll 150 subjects.
“The VIRTUE study is designed to understand how this Pulsed Field Ablation (PFA) platform can be used to treat a variety of patients,” Reddy said. “The Varipulse catheter and its integration with Carto holds promise to be a versatile tool for physicians treating many types of patients with atrial arrhythmias.”
POLARIS, the second study, looks at the use and 12-month effectiveness of pulmonary vein isolation (PVI). It also evaluates posterior left atrial wall ablation, a common ablation lesion set, using Varipulse. It enrolled the first cases in December 2023. Biosense Webster said it aims to enroll 180 patients with paroxysmal AFib and 180 patients with persistent AFib. It takes place across four centers in the U.S., led by Dr. Moussa Mansour of Massachusetts General Hospital.
“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.”