The OMNY-AF trial evaluates safety and efficacy of the investigational OMNYPULSE™ Platform, a novel catheter that combines a large ablation area with mapping capabilities
Irvine, CA – October 30, 2024 – Today, Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the enrollment completion of the pilot phase of the OMNY-AF clinical trial, a study which evaluates the investigational OMNYPULSE™ Platform in the treatment of symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia.
OMNY-AF is a prospective, single-arm, multi-center clinical trial that has completed the pilot phase enrollment of 30 patients and will enroll up to 410 additional patients in the pivotal phase across the United States and Australia. The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of the OMNYPULSE™ Platform for pulmonary vein isolation in the treatment of subjects with symptomatic paroxysmal AFib. The pivotal phase of the study will begin once the U.S. Food & Drug Administration (FDA) completes the review of the acute safety data from the pilot group.
The OMNYPULSE™ Platform, consisting of the OMNYPULSE™ Catheter and TRUPULSE™ Generator, is designed to enable AFib treatment strategies with a catheter that combines Pulsed Field Ablation (PFA) therapy and mapping via the CARTO™ 3 System, the world’s leading 3D heart mapping system. The investigational OMNYPULSE™ Catheter is a large-tip, 12 mm focal catheter with contact force sensing and a TRUEref™ reference electrode to reduce the impact of far-field unipolar signals.i The investigational TRUPULSE™ Generator provides a bipolar, biphasic pulse application to the catheter’s twelve electrodes. With the CARTO™ 3 System, clinicians are able to obtain a Pulsed Field Index value, which is a calculation using the real-time contact force feedback combined with the number of pulsed field applications.[1] This value can then be compared to the recommended Pulsed Field Index value, acting as an ablation target for a given location.
“The CARTO™ 3 System integrated with the OMNYPULSE™ Platform and the PF Index module allows me to correlate my ablation parameters with each lesion I create in real-time”, said Dr. Moussa Mansour,ii director of the atrial fibrillation program at Massachusetts General Hospital. “This tool could potentially increase procedure efficiency and treatment accuracy.”
“When treating AFib, mapping system integration is just as important with pulsed field energy as it was with other energy sources”, said Dr. Andrea Natale,iii Executive Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, who conducted one of the first patient cases. “The OMNYPULSE™ Platform is designed to provide PFA energy with contact force guidance and electroanatomical mapping with CARTO.”
“The OMNY-AF study is part of our ongoing efforts to equip electrophysiologists with the tools they need to efficiently and effectively conduct ablation procedures to drive positive outcomes for patients with AFib.” said Jennifer Currin, Ph.D., Vice President, Scientific Affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech. “The ability to make personalized treatment decisions with the help of an integrated solution that allows electrophysiologists to both evaluate and treat would bring tremendous value to doctors and patients.”
AFib is the most common type of cardiac arrhythmia and affects more than 8 million people in the U.S. and nearly 50 million people worldwide.[2] Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.[3] Despite these projections, about one-third of patients with AFib are not aware they have the condition, and AFib often goes unrecognized until the onset of complications.[4],[5] Catheter ablation is a safe and effective rhythm-control strategy for symptomatic AFib patients who do not benefit from medication.[6], iv
Earlier this year, Johnson & Johnson MedTech completed enrollment of the Omny-IRE clinical trial, which is evaluating the safety and efficacy of the OMNYPULSE™ Platform in Europe and Canada. Learn more about both studies and our approach to PFA. The OMNYPULSE™ Platform is under development and not available for sale in any region of the world.
About The OMNYPULSE™ Platform
The investigational OMNYPULSE™ Platform uses pulsed electrical field energy to produce targeted intracardiac lesions for the treatment of AFib. The platform includes the TRUPULSE™ 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 AFib.
About The OMNY-AF Study
The OMNY-AF study is a prospective, single-arm, multi-center study evaluating the clinical safety and effectiveness of the OMNYPULSE™ Catheter for the treatment of symptomatic paroxysmal AFib. Up to 440 enrolled subjects will undergo an ablation procedure with the OMNYPULSE™ Platform. The primary safety endpoint in the study is the occurrence of Primary Adverse Events within seven days of the ablation procedure.1 The primary effectiveness endpoint is freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia episodes based on electrocardiographic data and additional failure modes during the effectiveness evaluation period over a 12-month period.
Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circular restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit biosensewebster.com and connect on LinkedIn and X, formerly Twitter.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Biosense Webster, Inc. is a Johnson & Johnson MedTech company.
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. 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. Biosense Webster, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
[1] Biosense Webster. (2023). OMNYPULSE™ Bi-Directional Catheter IFU.
[2] 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.
[3] Staerk, L, Wang, B, Preis, SR et al. 2018 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. doi: 10.1136_bmj.k1453 | BMJ 2018;361:k1453
[4] Dilaveris PE, Kennedy HL. Silent Atrial Fibrillation: Epidemiology, Diagnosis, and Clinical Impact. Clin Cardiol. 2017;40:413–418.
[5] Benjamin EJ, Go AS, Desvigne-Nickens P, et al. Research Priorities in Atrial Fibrillation Screening: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop. Circulation. 2021;143:372–388.
[6] Loring Z, Matsouaka RA, Holmes DN. Procedural Patterns and Safety of Atrial Fibrillation Ablation.
