Johnson & Johnson’s Biosense Webster today announced the start of patient cases with the investigational Laminar LAAX system.
In November 2023, Johnson & Johnson MedTech completed a $400 million acquisition of Laminar, With that buy, the company brought in Laminar’s left atrial appendage elimination (LAAX) technology. Unlike other LAA technologies, which exclude or occlude the LAA, Laminar’s aims to completely eliminate it to treat AFib. Rather than use catheter-based devices to plug and occlude the LAA, Laminar’s approach utilizes rotational motion.
Irvine, California-based Biosense Webster commenced the patient cases as part of a pivotal FDA investigational device exemption (IDE) study. Dr. Saibal Kar (Los Robles Health System) and Dr. Devi Nair (St. Bernard’s Heart & Vascular Center) performed the procedures. Biosense Webster said they mark a “significant milestone” on the road to non-valvular AFib (NVAF) treatment.
The prospective, randomized, controlled, multicenter, open-label study aims to enroll 1,500 patients across up to 100 U.S. sites. It will evaluate patients with NVAF deemed appropriate for LAAX to reduce the risk of stroke and systemic embolism. The study compares the safety and efficacy of the Laminar LAAX system to commercially available LAA closure devices.
“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,” said Jennifer Currin, president of sicnetiic affairs, Cardiovascular & Specialty Solutions at J&J MedTech. “We look forward to learning more about how this innovative approach to LAA closure performs compared to currently available solutions.”