Biosense Webster has 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 Saibal Kar (Los Robles Health System, Thousand Oaks, USA) and Devi Nair (St Bernard’s Heart & Vascular Center, Jonesboro, USA), mark a significant milestone in the pursuit of innovative solutions for non-valvular atrial fibrillation (NVAF) treatment, the company says in a press release.
The prospective, randomised, controlled, multicentre, open-label pivotal clinical study aims to enrol 1,500 patients across up to 100 sites in the USA. 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.
Kar, principal investigator in the study, said: “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.”
Nair, also a principal investigator of the clinical trial, adds: “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.”
Jennifer Currin, vice president of scientific affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson MedTech, emphasised 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 a US Food and Drug Administration (FDA)-approved therapy for reducing the risk of thromboembolism in AF patients who are recommended for chronic oral anticoagulation therapy but have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
The acquisition of Laminar by Johnson & Johnson MedTech in November 2023, underscores the commitment to advancing cardiovascular care through innovation, the company’s press release states.
