Skip to content
HomeMedia CenterPress releases Medical technologiesBiosense Webster Begins Enrollment of Pivotal Trial Evaluating the Laminar Left Atrial Appendage Elimination Device 

Biosense Webster Begins Enrollment of Pivotal Trial Evaluating the Laminar Left Atrial Appendage Elimination Device 

Investigational device designed for Left Atrial Appendage Elimination (LAAX) to reduce the risk of stroke in patients with non-valvular atrial fibrillation

Share Article
share to

Irvine, CA – February 27, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced the commencement of patient cases with the investigational Laminar Left Atrial Appendage Elimination (LAAX) System as part of its pivotal investigational device exemption (IDE) study. The first procedures, performed by leading physicians Saibal Kar, MD, FACC, FSCAI, (Program Director, Cardiovascular Disease Fellowship, Los Robles Health System, California, HCA Healthcare National Physician Director, Interventional Cardiology) and Devi Nair, MD, FACC, FHRS, (Director, Cardiac Electrophysiology Division, St. Bernard’s Heart & Vascular Center, Jonesboro, Arkansas) mark a significant milestone in the pursuit of innovative solutions for non-valvular atrial fibrillation (NVAF) treatment.

The prospective, randomized, controlled, multicenter, open-label pivotal clinical study aims to enroll 1,500 patients across up to 100 sites in the United States.  Patients with NVAF deemed appropriate for LAAX to reduce the risk of stroke and systemic embolism, will participate in this research effort. The study will compare the safety and efficacy of the Laminar LAAX System to commercially available left atrial appendage (LAA) closure devices, providing a potential non-pharmacologic alternative for eligible patients. 

Dr. Kariii, Principal Investigator in the study, shared his positive experience with the Laminar LAAX System: “Los Robles was the leading enrolling site the US Early Feasibility Study (EFS) for this innovative approach to LAA elimination. It’s exciting to be part of the evolution of the latest technology into a tangible solution for treating patients. I look forward to seeing the results from this US clinical trial.”

Dr. Nairiii, also a Principal Investigator of the clinical trial, expressed enthusiasm about the potential impact on patients’ lives: “I am excited to be part of this clinical trial with the novel Laminar device. Stroke is a major concern for millions of people living with atrial fibrillation, and as physicians, we strive to deliver better outcomes for these patients.”

Atrial fibrillation (AFib) affects approximately 38 million patients globally, significantly increasing the risk of stroke1,2.  The LAA, a potential source of clot formation, contributes to thromboembolic stroke in patients with NVAF.  Unlike existing catheter-based plug devices, the investigational Laminar LAAX System utilizes rotational motion to eliminate the LAA, aiming to achieve closure with minimal surface area exposure to the left atrial chamber. 

Jennifer Currin, Ph.D., Vice President of Scientific Affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech, emphasized the potential of this innovation: “Building on positive evidence from the Early Feasibility Study, we believe the Laminar LAAX System has the potential to transform patient care by offering a viable alternative to long-term blood thinners.  We look forward to learning more about how this innovative approach to LAA closure performs compared to currently available solutions.”

LAA closure, is an FDA-approved therapy for reducing the risk of thromboembolism in atrial fibrillation patients who are recommended for chronic oral anticoagulation therapy but have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants2. This is particularly important for the nearly 40% of AFib patients who cannot tolerate long-term blood thinners3,4. 

The acquisition of Laminar, Inc. by Johnson & Johnson MedTech in November 2023, underscores the commitment to advancing cardiovascular care through innovation. 

About the Laminar LAAX Clinical Trial:
The pivotal IDE clinical trial will enroll 1,500 patients randomized 1:1 to evaluate the safety and efficacy of the Laminar System compared to FDA-approved LAAC devices for NVAF treatment.

About Biosense Webster:
Biosense Webster, a part of Johnson & Johnson MedTech, headquartered in Irvine, CA, leads in cardiac arrhythmia diagnosis and treatment worldwide, dedicated to advancing electrophysiology tools and solutions for improved patient care.  Learn more at www.biosensewebster.com and connect on LinkedIn and Twitter. 


About Johnson & Johnson MedTech:
Johnson & Johnson MedTech harnesses diverse healthcare expertise and purposeful technology to redefine medical intervention and enhance lives globally, across surgery, orthopedics, vision and interventional solutions.

Forward-Looking Statements:
This press release contains forward-looking statements regarding the Laminar LAAX System clinical trial as defined in the Private Securities Litigation Reform Act of 1995. 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. None 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. 

© Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_ALLB_317341

Media contact:
Diane Pressman
Dpressm1@its.jnj.com

Investor Relations:
Tracy Menkowski
investor-relations@its.jnj.com

i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii Los Robles Health System entered into a clinical trial agreement with Biosense Webster, Inc. for its participation in the Laminar LAAX IDE clinical trial. Dr. Saibal Kar serves as a primary study investigator and was not compensated for his contributions to this announcement.
iii St. Bernard’s Heart & Vascular Center entered into a clinical trial agreement with Biosense Webster, Inc. for its participation in the Laminar LAAX IDE clinical trial. Dr. Devi Nair serves as a primary study investigator and was not compensated for her contributions to this announcement.

1 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221.
2 Holmes, DR. Atrial fibrillation and stroke management: present and future Semin Neurol. 2010 Nov;30(5):528-36.
3 Marzec LN, Wang K, Shah ND, et al. Influence of Direct Oral Anticoagulants on Rates of Oral Anticoagulation for Atrial Fibrillation J Am Coll Cardiol. 2017 May, 69 (20) 2475–2484.
4 Baker CL, Dhamane AD, Mardekian J. et al. Comparison of Drug Switching and Discontinuation Rates in Patients with Nonvalvular Atrial Fibrillation Treated with Direct Oral Anticoagulants in the United States. Adv Ther. 2019 Jan;36(1):162-174.Adv Ther 36, 162–174 (2019).

You are now leaving jnj.com. The site you’re being redirected to is a branded pharmaceutical website. Please click below to continue to that site.