Sam Brusco, Associate Editor02.27.24
Johnson & Johnson MedTech company Biosense Webster has begun patient cases in its pivotal investigational device exemption (IDE) study using its investigational laminar left atrial appendage elimination (LAAX) system.
Biosense Webster plans to enroll 1,500 patient across up to 100 U.S. sites for the Laminar LAAX trial pivotal clinical trial. Patients with non-valvular atrial fibrillation (NVAF) deemed appropriate for LAAX to lower stroke and systemic embolism risk will be enrolled in the research effort, which will compare Laminar LAAX’s safety and efficacy to available LAA closure devices.
The first procedures were performed by Saibal Kar, MD, FACC, FSCAI, (Program Director, Cardiovascular Disease Fellowship, Los Robles Health System, 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.
Johnson & Johnson MedTech acquired the technology from Laminar in November 2023.
“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, Ph.D., VP of scientific affairs, cardiovascular, and specialty Solutions at Johnson & Johnson MedTech. “We look forward to learning more about how this innovative approach to LAA closure performs compared to currently available solutions.”
Earlier this month, Biosense Webster announced support for two collaborative studies of its Varipulse pulsed field ablation (PFA) platform, VIRTUE and POLARIS.
Biosense Webster plans to enroll 1,500 patient across up to 100 U.S. sites for the Laminar LAAX trial pivotal clinical trial. Patients with non-valvular atrial fibrillation (NVAF) deemed appropriate for LAAX to lower stroke and systemic embolism risk will be enrolled in the research effort, which will compare Laminar LAAX’s safety and efficacy to available LAA closure devices.
The first procedures were performed by Saibal Kar, MD, FACC, FSCAI, (Program Director, Cardiovascular Disease Fellowship, Los Robles Health System, 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.
Johnson & Johnson MedTech acquired the technology from Laminar in November 2023.
“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, Ph.D., VP of scientific affairs, cardiovascular, and specialty Solutions at Johnson & Johnson MedTech. “We look forward to learning more about how this innovative approach to LAA closure performs compared to currently available solutions.”
Earlier this month, Biosense Webster announced support for two collaborative studies of its Varipulse pulsed field ablation (PFA) platform, VIRTUE and POLARIS.