Data from five company-sponsored studies across radiofrequency ablation (RFA) and pulsed field ablation (PFA) modalities will be presented
Irvine, CA – January 23, 2023 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced that data from five company-sponsored studies, including two late breakers, will be presented at the 28th Annual International AF Symposium in Boston from February 2–4. The studies span innovations in radiofrequency ablation (RFA) and pulsed field ablation (PFA) and are part of Biosense Webster, Inc.’s long-standing commitment to advancing electrophysiology innovation.
"With so many exciting advancements on the horizon in electrophysiology, Biosense Webster, Inc. is looking forward to connecting with our customers and partners at AF Symposium and showcasing our new, innovative solutions in cardiac arrhythmia diagnosis and treatment,” said Anthony Hong, Vice President, Preclinical and Clinical Research and Medical Affairs, Cardiovascular and Specialty Solutions, Johnson & Johnson MedTech. “As a long-standing leader in this space, we are committed to harnessing the latest science and technology and working in collaboration with physicians to deliver best-in-class solutions.”
Data from five Biosense Webster, Inc.-sponsored studies will be presented, spanning key topics in electrophysiology. Highlights and timing include:
- Late-breaker presentation: Paroxysmal AF Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated with a 3D Mapping System: One-Year Outcomes of the Multicenter inspIRE Study. Presented February 3, 5:00-6:30 p.m. EST by Dr. Vivek Reddy
This analysis is the first look at data from Biosense Webster, Inc.’s inspIRE clinical trial – a prospective, multicenter, nonrandomized study conducted in Europe to evaluate the safety and efficacy of Biosense Webster, Inc.’s investigational VARIPULSE™ Catheter and TRUPULSE™ Generator in treating symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib).1
- Late-breaker presentation: Multielectrode Radiofrequency Balloon Catheter for Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation: Outcomes from the Multicenter, Worldwide STELLAR Study. Presented February 3, 5:00-6:30 p.m. EST by Dr. Sandeep Goyal
The presentation will highlight results from the STELLAR study – an FDA-regulated investigational device exemption study conducted in the US, China and Italy to assess the safety and efficacy of pulmonary vein isolation (PVI) using the HELIOSTAR™ Balloon Ablation Catheter in drug refractory symptomatic paroxysmal AFib.2
- Poster Presentation: Assessment of Optimal Dose-Response Using a Circular Pulsed Field Ablation Catheter. Presented February 2-3 in the main exhibit hall by Dr. Jonathan Hsu
The objective of this study was to assess the efficacy and safety of various PFA doses delivered intracardially using a circular catheter in a porcine model.
- Poster Presentation: Real-World Experience Comparing Zero Versus Conventional Fluoroscopy Catheter Ablation for the Treatment of Symptomatic Persistent Atrial Fibrillation. Presented February 2-3 in the main exhibit hall by Dr. Mark Metzl
This study aimed to evaluate the safety, effectiveness, and efficiency of zero-fluoroscopy symptomatic persistent atrial fibrillation ablation in a real-world setting.
- Poster Presentation: Intracardiac Echocardiography Versus Transesophageal Echocardiogram Imaging During Catheter Ablation for Atrial Fibrillation: A Multi-Hospital Retrospective Database Analysis. Presented February 2-3 in the main exhibit hall by Dr. Rhea Pimentel
This study compared healthcare use outcomes among AFib patients undergoing ablation with intracardiac echocardiography versus transesophageal echocardiogram.
Interactive In-Booth Experiences
Biosense Webster, Inc.’s exhibit booth #111 will feature opportunities for attendees to interact with the company’s latest innovations, including OCTARAY™ Mapping Catheter with TRUEref™ Technology, OPTRELL™ Mapping Catheter, QDOT MICRO™ Catheter and NUVISION™ Ultrasound Catheter.
For more information about Biosense Webster Inc.’s presence at AF Symposium and the conference schedule, please visit afsymposium 2023 Program.
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 MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at biosensewebster.com and connect on LinkedIn and Twitter.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTechi, 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 data from five Biosense Webster, Inc.-sponsored studies. The first study reviews one-year outcomes of the Multicenter inspIRE Study. The second study reviews outcomes from the Multicenter, Worldwide STELLAR Study. The third study referenced above assessed the efficacy and safety of various PFA doses delivered intracardially using a circular catheter in a porcine model. The fourth study referenced above evaluated the safety, effectiveness, and efficiency of zero-fluoroscopy PsAF ablation in a real-world setting. The fifth study analyzed Intracardiac Echocardiography Versus Transesophageal Echocardiogram Imaging During Catheter Ablation for Atrial Fibrillation using Multi-Hospital Retrospective Database. 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; 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 2, 2022, 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 Biosense Webster, Inc., the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
- Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
- ClinicalTrials.gov. A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspire). Accessed January 11, 2023.
- ClinicalTrials.gov. Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR). Accessed January 11, 2023.
© Biosense Webster, Inc. 2023 237340-230109