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Biosense Webster inspIRE Clinical Study Shows 100% Acute Procedural Success in Initial Data
Live presentation at ESC Congress 2021 showcases initial clinical experience with the novel pulsed field ablation system for paroxysmal atrial fibrillation ablation, resulting in acute procedural success in 100% of study subjects with no procedural adverse events1***
IRVINE, CA – August 27, 2021 – Biosense Webster, the global leader in cardiac arrhythmia treatment and part of the Johnson & Johnson Medical Devices Companies*, announced today that data from the inspIRE clinical trial was presented at the ESC Congress 2021, organized by the European Society of Cardiology, taking place virtually from August 27-30. inspIRE is a prospective, multi-center, non-randomized study evaluating the safety and effectiveness of the investigational VARIPULSE™ Catheter and TRUPULSE™ Generator, which uses pulsed field ablation (PFA) in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation, with planned enrollment of up to 550 patients.
Today at ESC Congress 2021, initial results of 35 subjects were presented by Dr. Tom de Potter**, MD, FEHRA, Associate Director, Cardiovascular Center Department of Cardiology, Electrophysiology Section at OLV Hospital. The data showed acute procedural success (pulmonary vein isolation) was achieved in 100% of the study subjects with no procedural adverse events. Additionally, the findings agree with prior observations of the tissue-selectiveness of PFA in preclinical studies2,3,4,5 and the study exhibited low procedure time of 82.4±20.0 minutes. The pivotal phase of the study will continue to evaluate the 12-month safety and effectiveness.1***
"Pulsed field ablation marks a new era of treating atrial fibrillation for electrophysiologists. These positive results are exciting as we continue to evaluate the safety and efficacy of PFA and bring this new approach forward," said Dr. de Potter. "I am encouraged by this data and looking forward to seeing continued results so that we can help bring safer, more efficient treatments to our atrial fibrillation patients.”
PFA represents an emerging approach to treating atrial fibrillation. This technique utilizes a controlled electric field to ablate and scar cardiac tissue through a process called irreversible electroporation (IRE). As it does not rely on thermal effects to ablate target cardiac tissue, IRE offers the potential to reduce the risk of esophageal, pulmonary vein and phrenic nerve injury. The investigational VARIPULSE Catheter is a steerable, multi-electrode, catheter enabling cardiac electrophysiological mapping (stimulating and recording) and ablation functionalities through the investigational TRUPULSE Generator.
“These promising inspIRE study results mark an important first step in evaluating the potential of this novel treatment option to patients suffering from cardiac arrhythmias,” said Uri Yaron, Worldwide President, Biosense Webster, Inc. “We’re committed to the electrophysiology community and transforming the types of treatments they can offer patients. We look forward to seeing additional results as this trial continues.”
In September 2020, Biosense Webster announced that it had enrolled and treated the first patients in the inspIRE clinical study in Europe****, evaluating safety and effectiveness of the VARIPULSE Catheter and TRUPULSE Generator. VARIPULSE Catheter is an investigational technology and is not approved by regulatory bodies in any market today. To learn more about the inspIRE study, visit clinicaltrials.gov. Registration NCT04524364.
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia, affecting an estimated 33 million people globally.6 Estimates state that by 2030 the number of people with AF is projected to increase by up to 70 percent.7
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 Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere. For more information, visit www.jnjmedicaldevices.com.
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 Medical Devices 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 Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
** Dr. de Potter is a paid consultant to Biosense Webster, Inc.
*** Success defined as freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) within 91-365 days post-index procedure greater than or equal to (>=) 30 seconds
- DePotter T et al. Initial clinical experience with the novel pulsed field ablation system for paroxysmal atrial fibrillation ablation: results from the inspIRE trial. Presented at ESC Congress 2021. August 2021.
- van Driel VJ et al. Low vulnerability of the right phrenic nerve to electroporation ablation. Heart Rhythm.
- Neven K et al. Acute and Long-Term Effects of Full-Power Electroporation Ablation Directly on the Porcine Esophagus. Circ Arrhythmia Electrophysiology. 2017;10:e004672.
- du Pré BC et al. Minimal coronary artery damage by myocardial electroporation ablation. Europace. 2013;15:144–149.
- van Driel VJ et al. Pulmonary Vein Stenosis After Catheter Ablation Electroporation Versus Radiofrequency. Circ Arrhythmia Electrophysiology. 2014;7:734–738.
- 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.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
VARIPULSE Catheter and TRUPULSE Generator are under development and do not bear the CE Mark. They are approved for investigational use only and are not available for sale in the EU.
This publication is not intended for distribution outside of the EMEA region.
© Johnson & Johnson Medical NV/SA 2021 185553-210825 EMEA