News | Atrial Fibrillation | February 27, 2024

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 

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

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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. Karii, 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." 

What is Atrial Fibrillation?

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. 

For more information: www.biosensewebster.com


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