Okami Medical today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company's LOBO Vascular Occlusion System.
The LOBO (LOw-profile Braided Occluder) system, purpose-built for fast and complete occlusion of a diverse set of peripheral arterial targets, now includes LOBO-3, LOBO-5, LOBO-7 and LOBO-9.
The LOBO occluders integrate patented HDBRAID technology and an innovative design to provide interventional physicians with a one-and-done solution for embolization. The highly occlusive braided structure rapidly reduces flow and enables single-device occlusions of blood vessels throughout the body. LOBO-7 and LOBO-9 are intended for use in 5 to 7 mm and 7 to 9 mm diameter vessels, respectively. LOBO-3 and LOBO-5, both previously FDA cleared, are intended for use in 1.5 to 3 mm and 3 to 5 mm diameter vessels, respectively.
"LOBO represents the next evolution in vascular embolization. As opposed to coils, which rely on the formation of an irregular mass with relatively large voids to try to occlude vessels, LOBO utilizes a high density, uniform small pore structure to occlude vessels nearly instantly," said Raj Pyne, MD, FSIR, interventional radiologist at Rochester Regional Health. "The ability to occlude vessels quickly and consistently with a single-device not only improves procedure efficiency, but also is critical and often life-saving in situations such as trauma and unstable bleeding. The smaller occluders, LOBO-3 and LOBO-5, have demonstrated excellent performance and I am excited to see the larger sizes in use."