First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter

Johnson & Johnson Medical Devices Companies’ Biosense Webster, Inc., says the first patients have been enrolled and treated in its inspIRE clinical study in Europe.

Background

AF is the most common type of cardiac arrhythmia affecting an estimated 33 million people globally. By 2030 the number of people with Atrial Fibrillation (AF) is projected to increase by up to 70 percent.

A variety of techniques, catheter designs and energy sources have been investigated to advance the treatment of AF. Pulsed Field Ablation (PFA) represents a new approach, utilizing a controlled electric field – instead of thermal energy – to ablate and scar cardiac tissue through a process called irreversible electroporation (IRE). This ablation technique may spare other tissue types from inadvertent ablation, including the esophagus, pulmonary vein connective tissue and the phrenic nerve (which controls the diaphragm).

The inspIRE study will evaluate the safety and effectiveness of the VARIPULSE® Catheter and TRUPULSE™ Generator, investigational technologies using PFA, in treating symptomatic drug refractory recurrent paroxysmal (intermittent) AF. It is a prospective, multi-center, non-randomized, study that will enroll more than 300 patients who will be treated with the investigational VARIPULSE Catheter, a steerable, multi-electrode, catheter enabling cardiac mapping and PFA using the investigational TRUPULSE Generator.

Investigator comments

“IRE has the potential to be a disruptive breakthrough for PVI, and I have high expectations,” said Tom de Potter, MD, FEHRA, Associate Director, Cardiovascular Center Department of Cardiology, Electrophysiology Section at OLV Hospital. “After completing several cases, I am now even more eager to see the final safety and efficacy results.”

Company comments

“The inspIRE study is an important step toward a potentially significant advancement in treatment options for atrial fibrillation patients,” said Uri Yaron, Worldwide President, Biosense Webster, Inc. “We eagerly await data from the study as more investigators have access to this novel technology aimed at advancing the treatment of cardiac arrhythmias.”

Source: Biosense Webster, Inc.

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