Okami Medical today said it received FDA 510(k) clearance for its LOBO-5 Vascular Occluder.
The Low-profile Braided Occluder (LOBO) system is designed to provide interventional physicians with single device for the occlusion of a wide range of peripheral arterial targets. It combines neurovascular-derived HDBraid technology to create a highly occlusive structure for fast and efficient closure of blood vessels throughout the body. LOBO-5 is intended for use in 3 to 5mm diameter vessels.
“The FDA clearance of LOBO-5 marks another milestone in our mission to provide patients and physicians with access to advanced technologies that address the numerous unmet clinical needs in peripheral vascular occlusion,” president and CEO Bob Rosenbluth said in a news release. “LOBO-3 and LOBO-5, to be followed by LOBO-7 and LOBO-9, are designed and built to enable fast, predictable and complete occlusion of a diverse set of vascular targets without the need for multiple embolic devices.”