Biosense Webster starts enrolment for Laminar LAAX device trial

28 Feb 2024
www.nsmedicaldevices.com
AcquisitionClinical Study
Laminar's technology is designed to remove the left atrial appendage entirely in order to treat Atrial fibrillation, in contrast to existing catheter-based plug devices Biosense Webster begins enrollment of LAAX device trial. (Credit: valelopardo from Pixabay) Johnson & Johnson MedTech’s Biosense Webster has started the patient cases with the investigational Laminar Left Atrial Appendage (LAA) elimination device under its investigational device exemption (IDE) study. Johnson & Johnson MedTech completed the $400m acquisition of Laminar in November 2023. The acquisition included Laminar’s left atrial appendage elimination (LAAX) technology. Laminar’s technology is designed to remove the left atrial appendage (LAA) to reduce the risk of stroke in patients with non-valvular atrial fibrillation. The Laminar LAAX System uses rotational motion to eliminate LAA and achieve closure with minimal surface area exposure to the left atrial chamber, a process different from existing catheter-based plug devices. Johnson & Johnson MedTech Cardiovascular & Specialty Solutions scientific affairs VP Jennifer Currin said: “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.” The goal of the multicentre, open-label, prospective, randomised, controlled, and clinical trial is to enrol 1,500 patients at up to 100 sites in the US. It will recruit patients with non-valvular atrial fibrillation (NVAF) who were judged suitable for LAAX to lower the risk of stroke and systemic embolism. The study will randomise patients 1:1 to compare the safety and effectiveness of the Laminar LAAX System against commercially available LAA closure devices. This will provide a potential non-pharmacologic alternative for eligible patients, California, US-based Biosense Webster said. The first procedures were performed by physicians Saibal Kar and Devi Nair. Kar said: “Los Robles was the leading enrolling site for 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.”
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