News | Atrial Fibrillation | May 02, 2022

First Patients in the U.S. Enrolled in Biosense Webster Clinical Study To Evaluate VARIPULSE Catheter for Atrial Fibrillation

admIRE study will evaluate safety and effectiveness of investigational Pulse Field Ablation (PFA) technologies in treating symptomatic drug refractory recurrent intermittent atrial fibrillation.

ECG showing Atrial Fibrillation

Image credit: Getty Images


May 2, 2022 – Johnson & Johnson MedTech have announced that Biosense Webster, Inc., a worldwide leader in the science and technology of cardiac arrhythmia treatment, enrolled the first patients in its admIRE clinical study in the United States. admIRE is a prospective, multi-center, non-randomized study that will enroll more than 400 patients in the U.S. to evaluate the safety and effectiveness of Biosense Webster’s Pulsed Field Ablation (PFA) Platform, the principal components of which are the VARIPULSE Catheter and the TRUPULSE Generator. The study will evaluate the Platform for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and ablation procedures while also evaluating the incidence of primary adverse events within seven days post-procedure.
 
Atrial Fibrillation (AF) is the most common type of cardiac arrhythmia affecting an estimated 33 million people globally1. By 2030 the number of people with AF is projected to increase by up to 70 percent2. This ablation technique may help spare other tissue types from inadvertent injury to adjacent structures such as the esophagus, pulmonary vein connective tissue and the phrenic nerve.3

“The enrollment of the first patient in the admIRE study marks an important milestone in our journey to bring forward a best-in-class PFA platform to our customers, who have come to depend on Biosense Webster’s broad, reliable and innovative suite of tools for diagnosing and treating AF,” said Michael Bodner, Ph.D, Worldwide President, Biosense Webster. “Biosense Webster is committed to investing in the development of innovative PFA solutions to address the needs of electrophysiologists and patients.”

In September 2020, Biosense Webster announced that it had enrolled the first patients in the inspIRE clinical study in Europe , evaluating safety and effectiveness of the VARIPULSE Catheter and TRUPULSE Generator. In August 2021, Biosense Webster announced initial data from the inspIRE study at the ESC Congress 2021 demonstrating acute procedural success4 in 100% of study subjects with no procedural serious adverse events.

The VARIPULSE Catheter and TRUPULSE Generator are investigational technologies and are not approved by regulatory bodies in any market today.

To learn more about the admIRE study, visit www.clinicaltrials.gov.   

Reference:

1. Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation 2014;129:837-47.

2. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S (2014) Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 6: 213-220.

3. Verma, A. et al (2021). Primer on Pulsed Electrical Field Ablation: Understanding the Benefits and Limitations. Circulation. Arrhythmia and electrophysiology14(9), e010086.

4. Acute Procedural Success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge. Use of a non-study catheter to achieve PVI is considered an acute procedural success failure.

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