Study evaluates the safety and effectiveness of the OMNYPULSE™ Platform in Europe and Canada
Irvine, CA – August 26, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced the enrollment completion of the Omny-IRE clinical trial. Omny-IRE is a prospective, multi-center, non-randomized clinical trial that enrolled 188 patients in Europe and Canada to evaluate the safety and effectiveness of the Biosense Webster OMNYPULSE™ Platform for the mapping and treatment of symptomatic paroxysmal atrial fibrillation (AFib) during standard ablation procedures.1
“With the Omny-IRE trial now fully enrolled, we are continuing to make important progress in advancing our collective knowledge and understanding of PFA,” said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “Our hope is that the integrated OMNYPULSE™ Platform will be an exciting new tool in a versatile portfolio of PFA solutions that Biosense Webster is advancing to provide electrophysiologists with a suite of tools they need to deliver optimal procedures for their patients.”
The OMNYPULSE™ Platform, consisting of the OMNYPULSE™ Catheter and TRUPULSE™ Generator, combines PFA therapy and mapping via the CARTO™ 3 System, the world’s leading 3D electroanatomical mapping system. The investigational OMNYPULSE™ Catheter is the first large-tip, 12 mm focal catheter with contact force sensing and a TRUEref™ reference electrode to reduce the impact of far-field unipolar signals.ii The investigational TRUPULSE™ Generator provides a bipolar, biphasic pulse application to the catheter’s twelve electrodes. With the CARTO™ 3 System software used in the study, clinicians were able to obtain a Pulsed Field (PF) Index value for each ablation, which is a calculation using the real-time contact force feedback combined with the number of pulsed field applications.2
“In the cases I performed as part of the Omny-IRE trial, the integrated OMNYPULSE™ Platform enabled me to both map and deliver pulsed field energy in a seamless way,” said Mattias Duytschaever, M.D., Ph.D., Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, Belgium.iii “The contact force data from the OMNYPULSE™ Catheter gave me confidence regarding tissue contact before the ablation, and then enabled the PF Index calculation during energy delivery.”
“It is exciting to play a part in advancing the field of PFA through clinical trials such as Omny-IRE,” said Johan Vijgen, M.D., FHRS, FESC, Department of Cardiology, Chief, Division of Electrophysiology, Jessa Hospital, Hasselt, Belgium.iv “In my experience with the OMNYPULSE™ Platform as part of the study, I found the PF Index and contact-force feedback very valuable in making patient-tailored treatment decisions during the procedures.”
Catheter ablation is a minimally-invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (Radiofrequency ablation) or cold (Cryoablation).3 PFA represents a new approach to treating AFib, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heart beat through a process called irreversible electroporation (IRE).4 Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.4
AFib is the most common type of cardiac arrhythmia and impacts nearly 50 million people worldwide,5 and 11 million people in Europe alone.6 Today, about 1 in 4 adults over the age of 40 are at risk for developing AFib.7 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid risk of stroke and disease progression.8
To learn more about the Omny-IRE study, visit here. The OMNYPULSE™ Platform is investigational and not available for sale or distribution in any market.
About The OMNYPULSE™ Platform
The investigational OMNYPULSE™ Platform uses pulsed electrical field energy to produce targeted intracardiac lesions for the treatment of atrial fibrillation. The platform includes the TRUPULSE™ multichannel generator and multi-electrode OMNYPULSE™ Catheter used in conjunction with the CARTO™ 3 System with the VISITAG SURPOINT™ Module PF Index to provide electroanatomical maps, contact force sensing, PF Index values and catheter localization information for ablations for the treatment of paroxysmal atrial fibrillation.
About The Omny-IRE Study
Omny-IRE is a pivotal, prospective, multi-center, non-randomized study in Europe and Canada to demonstrate the safety and effectiveness of Biosense Webster’s OMNYPULSE™ Platform, the principal components of which are the OMNYPULSE™ Catheter and the TRUPULSE™ Generator. The study is evaluating the system for the treatment of symptomatic paroxysmal atrial fibrillation during standard electrophysiology mapping and ablation procedures while also evaluating the incidence of primary adverse events within seven days post-procedure.
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 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 the OMNYPULSE™ Platform clinical trials. 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 Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
i. Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii. Sarkozy AV, Johan; De Potter, Tom; Schilling, Richard; Markides, Vias (2020) Higher Density Mapping Efficiencies and Ease of Maneuverability from the OCTARAY First in Man Study. European Heart Rhythm Association 2020. Vienna, Austria. March 29th-31st, 2020. Pending formal publication.
iii. AZ Sint-Jan Hospital entered into a clinical trial agreement with Biosense Webster, Inc. for their participation in the Omny-IRE Study. Dr. Duytschaever served as a study coinvestigator. Dr. Duytschaever serves as a consultant for BWI. Dr. Duytschaever was not compensated for this authorship contribution.
iv. Jessa Hospital entered into a clinical trial agreement with Biosense Webster, Inc. for their participation in the Omny-IRE study. Dr. Vijgen served as a study coinvestigator. Dr. Vijgen serves as a consultant for BWI. Dr. Vijgen was not compensated for this authorship contribution.
- A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator (Omny-IRE). Clinicaltrials.gov. Accessed August 9, 2024.
- Biosense Webster. (2023). OMNYPULSE™ Bi-Directional Catheter IFU.
- British Heart Foundation. Catheter Ablation. Available here. Last accessed: January 2024.
- Reddy VY, Neuzil P, Koruth JS, et al. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. JACC 2019;74(3)315-326.
- Mensah, G, Fuster, V, Murray, C. et al. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec, 82 (25) 2350–2473.
- Global Burden of Disease Collaborative Network (2016) Global Burden of Disease Study 2016 (GBD 2016) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017.
- Staerk L, et al. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018 Apr 26;361:k1453.
- Kuck et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. PMID: 33330909.
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