Enrollment Commences in Pivotal Trial of Biosense Webster Laminar LAAX Device

February 27, 2024—Biosense Webster, Inc., a part of Johnson & Johnson MedTech, 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 of the system.

The investigational Laminar LAAX system uses rotational motion to eliminate the left atrial appendage (LAA), aiming to achieve closure with minimal surface area exposure to the left atrial chamber.

Biosense Webster stated that the prospective, randomized, controlled, multicenter, open-label pivotal clinical trial will compare the safety and efficacy of the Laminar LAAX system to an FDA-approved, commercially available LAA closure device as a potential nonpharmacologic alternative for eligible patients.

The study aims to enroll 1,500 patients, randomized 1:1, across up to 100 sites in the United States. Patients enrolled in the study will have nonvalvular atrial fibrillation (NVAF) that is deemed appropriate for LAAX to reduce the risk of stroke and systemic embolism.

According to the company, the first procedures mark a milestone in its pursuit of innovative solutions for NVAF treatment. Johnson & Johnson MedTech acquired Laminar, Inc. in November 2023.

The initial procedures were performed by Principal Investigators Saibal Kar, MD, and Devi Nair, MD.

Dr. Kar is Program Director of the Cardiovascular Disease Fellowship at Los Robles Health System in Thousand Oaks, California, as well as HCA Healthcare National Physician Director of Interventional Cardiology. Dr. Nair is Director of the Cardiac Electrophysiology Division at St. Bernard’s Heart & Vascular Center in Jonesboro, Arkansas.

“Los Robles was the leading enrolling site for the United States early feasibility study for this innovative approach to LAA elimination,” commented Dr. Kar in the company’s press release. “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 United States clinical trial.”

Dr. Nair added, “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.”