12-month results from admIRE pivotal trial with investigational VARIPULSE™ Platform
to be unveiled in late-breaking session
Real-world data from company-funded REAL AF registry to be showcased in 24 abstracts at the meeting
Irvine, CA – May 16, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announced data from 42 company sponsored or funded studies, including two late-breaking abstracts. The data will be presented at the Heart Rhythm Society (HRS) Annual Meeting in Boston from May 16-19. The studies span multiple innovations in Biosense Webster’s broad portfolio of catheter ablation solutions, including radiofrequency (RF) and pulsed field ablation (PFA) technology, workflow improvement, health economics, and market access.
“Through a deliberate focus on innovation and differentiation across our portfolio, and a commitment to meeting unmet needs for electrophysiologists and their patients, we are investing in research and evidence generation to help advance the standard of care in catheter ablation and improve the lives of people living with AFib,” said Jasmina Brooks, President, Biosense Webster. “At this year’s HRS Annual Meeting, we are looking forward to showcasing the latest advancements in cardiac ablation, connecting with EP community, and continuing to foster diversity and inclusion in the field.”
In addition to the data presented at HRS, Biosense Webster is pleased to sponsor programs in partnership with Heart Rhythm Society with a shared vision of advancing diversity and inclusion in electrophysiology and among the next generation of electrophysiologists (EPs). These programs include the Growth and Leadership Opportunities for Women in Electrophysiology (GLOWE), focused on empowering female EPs in the field, as well as the Growth and Leadership Opportunity for Black Electrophysiologists (GLOBE), focused on developing opportunities to increase their visibility within their institutions and the EP space. Also at the meeting, Biosense Webster will celebrate the legacy of one of the company’s founders – Wilton Wells Webster, with the presentation of the 2024 Will Webster Awards.
Highlights of data being presented include:
Late-breaker presentation: Long-Term Safety Effectiveness After Paroxysmal Atrial Fibrillation Pulsed Field Ablation from the U.S. Multicenter admIRE Study. LB-469804 / Ballroom East West May 17, 4:45 p.m. EDT, by Dr. Vivek Reddy, Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital, and The Helmsley Charitable Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinaii
Late-breaker presentation: Short-and long-term clinical outcomes from Real AF. LB-469809-03 / Ballroom East West May 18, 2:30 p.m. EDT by Dr. Paul Zei, Director, Comprehensive Atrial Fibrillation Program, Cardiovascular Medicine, Brigham and Women’s Hospitalii
Oral Presentation: Luminal Esophageal Temperature and Esophageal Damage by Left Atrial Pulsed Field Ablation. AB-482898-003 / Room 252 May 18, 8:24 a.m. EDT, by Dr. Armen Kocharian, Senior Imaging Physicist, Houston Methodist DeBakey Cardiology Associatesiii
Moderated Poster Presentations: As the sole corporate sponsor of the REAL-AF database – a group of more than 50 leading centers investigating real-world safety and effectiveness of catheter ablation procedures, health outcomes, research, and the future of electrophysiology practice – Biosense Webster supports the presentation of 24 abstracts of investigator-initiated trials stemming from the REAL AF database, 3 of which will be highlighted in moderated poster presentations:
- Left Atrial Low-Voltage Area Analysis Determines a Lack of Association Between Stroke Risk Factors and Atrial Fibrillation Subtypes – A REAL-AF Study. MP-483492-008 / Moderated Poster Hub 3, May 17, 11:55 a.m. EDT, by Dr. Andrew Nguyen,Keck Medicine at USCiv
- Catheter Ablation of Paroxysmal Atrial Fibrillation in Patients with Heart Failure and Reduced Ejection Fraction is Equally Safe and Effective as in Patients with Heart Failure and Preserved Ejection Fraction: Results from the REAL AF Registry. MP-483497-009 / Moderated Poster Hub 3, May 18, 12:05 – 12:10 p.m. EDT, by Dr. Carolina Hoyos, Cardiac Arrythmia Service, Brigham and Women’s Hospital, Harvard Medical Schoolv
- Continuous Versus Patch ECG Monitoring Following Catheter Ablation of AF in the REAL AF registry. MP-483498-009 / Moderated Poster Hub 3, May 18, 3:05 – 3:10 p.m. EDT, by Dr. Chinmaya Mareddy, Cardiac Electrophysiologist, Central Healthvi
Poster Presentation: Pulsed Field Ablation to Treat Atrial Fibrillation and Related Arrythmias Resembling Unusual Clinical Practice: Initial Results of VIRTUE. PO-06-175, Abstract Pavilion, May 19, 9:30 to 11:30 a.m. EDT, by Dr. Daniel Musikantow, Assistant Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinaivii The VIRTUE study evaluated the versatility of the VARIPULSE™ Platform in treating additional atrial arrhythmias including atrial fibrillation and atrial flutter.
The data presented at HRS build on other clinical evidence presented by Biosense Webster in recent months in support of its broad portfolio of electrophysiology solutions. The company recently announced three-month results from the SmartfIRE clinical trial at the annual meeting of the European Heart Rhythm Association (EHRA) which showed the use of the investigational Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter during standard electrophysiology mapping and ablation procedures in drug refractory symptomatic paroxysmal AFib patients led to a 100% acute procedural success, with 96.8% no acute reconnections shown in the veins.1 The company also recently announced the launch of CARTO™ 3 System Version 8, the latest version of the Company’s leading three-dimension (3D) heart mapping system used in cardiac ablation procedures, designed to increase efficiency, reproducibility, and accuracy in catheter ablation procedures.
Visit Biosense Webster at booth #629 to explore our innovative, investigative products, including the recently launched CARTO® 3 System Version 8 software which features new modules incorporating machine learning to increase efficiency and accuracy, the QDOT MICRO™ Catheter, NUVISION™ Ultrasound Catheter, and to learn more about the zero fluoroscopy workflow enabled by Biosense Webster technology.
The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is not available for sale in any region, and does not have regulatory approval. The VARIPULSE™ Catheter is pending FDA approval in the United States.
Media contact:
Diane Pressman
[email protected]
Charlene DeBar
[email protected]
Investor Relations:
Tracy Menkowski
[email protected]
About Biosense Webster
Biosense Webster, part of Johnson & Johnson MedTech, leads in cardiac arrhythmia diagnosis and treatment worldwide. We are dedicated to advancing electrophysiology and interventional cardiology tools and solutions for improved patient care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
About Johnson & Johnson MedTechviii
At Johnson & Johnson MedTech,viii 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 the VARIPULSE™ Platform, Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, CARTO ™ 3 System Version 8, the QDOT MICRO™ Catheter, and the NUVISION™ Ultrasound Catheter. 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. 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; 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 healthcare products and services; and trends toward healthcare 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 December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at sec.gov, jnj.com or on request from Johnson & Johnson. Neither of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments
- Duytschaever M, et al. Safety, effectiveness and PVI durability of contact force-sensing dual energy focal ablation technology integrated with 3D mapping to treat paroxysmal atrial fibrillation: SmartfIRE study results. Presented during the annual meeting of the European Heart Rhythm Association (EHRA), on 9th April 2024.
i. Dr. Reddy served as a study investigator and as a consultant for BWI. Dr. Reddy was not compensated for this authorship contribution.
ii. Dr. Zei served as a study investigator and as a consultant for BWI. Dr. Zei was not compensated for this authorship contribution.
iii. Dr. Kocharian served as a study investigator and as a consultant for BWI. Dr. Kocharian was not compensated for this authorship contribution.
iv. Dr. Nguyen served as a study investigator and as a consultant for BWI. Dr. Nguyen was not compensated for this authorship contribution.
v. Dr. Hoyos served as a study investigator and as a consultant for BWI. Dr. Hoyos was not compensated for this authorship contribution.
vi. Dr. Mareddy served as a study investigator and as a consultant for BWI. Dr. Mareddy was not compensated for this authorship contribution.
vii Dr. Musikantow served as a study investigator and as a consultant for BWI. Dr. Musikantow was not compensated for this authorship contribution.
viii. Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
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