admIRE study will evaluate safety and effectiveness of investigational Pulse Field Ablation (PFA) technologies in treating symptomatic drug refractory recurrent intermittent atrial fibrillation
IRVINE, CA – April 29, 2022 – Johnson & Johnson MedTech* announced today 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 success** 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.
Key Clinician Quotes on admIRE and PFA
“I am pleased to see that Biosense Webster is developing a PFA system designed to be fully integrated with the CARTO™ 3 System and could enable real-time catheter visualization with electro-anatomical mapping. It’s exciting to be part of the transformation of the latest science and technology innovation into tangible tools for treating patients.” Moussa Mansour, M.D., Massachusetts General Hospital***
"Pulsed field ablation has the potential to change the way electrophysiologists treat atrial fibrillation and improve the lives of patients. I look forward to continuing to evaluate the safety and efficacy of PFA in order to bring this new approach forward.” Andrea Natale, M.D., F.H.R.S, F.A.C.C., F.E.S.C at Texas Cardiac Arrhythmia Research Foundation***
“With Atrial Fibrillation continuing to grow in prevalence around the world, electrophysiologists are looking for innovative approaches that will drive procedure efficiency and help us deliver better patient outcomes. I am pleased to be part of the admIRE clinical study to evaluate this investigational PFA solution for electrophysiology mapping and ablation procedures.” David Newton, M.D., Memorial Health University Medical Center***
About Biosense Webster, Inc.
Biosense Webster, Inc., is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of the Johnson & Johnson Family of Companies, the specialized medical-technology company is headquartered in Irvine, Ca., and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at www.biosensewebster.com and connect on LinkedIn and Twitter.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, 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 VARIPULSE™ Catheter and TRUPULSE™ Generator. The reader is cautioned not to rely on these forward-looking statements. 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., any of the other Johnson & Johnson MedTech companies 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; manufacturing difficulties and delays; 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 health care products and services; and trends toward health care 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 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc., the Johnson & Johnson MedTech nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*The Johnson & Johnson MedTech Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
***Drs. Mansour, Newton and Natale are paid consultants to Biosense Webster, Inc.
** 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.
- 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.
- Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S (2014) Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 6: 213-220.
- Verma, A. et al (2021). Primer on Pulsed Electrical Field Ablation: Understanding the Benefits and Limitations. Circulation. Arrhythmia and electrophysiology, 14(9), e010086.
© Biosense Webster, Inc. 2022