Okami Medical has revealed the expansion of its LOBO vascular occlusion system product line with US Food and Drug Administration (FDA) 510(k) clearance of the LOBO-5 vascular occluder.
According to a press release from the company, the LOBO (Low-profile braided occluder) system is uniquely designed to provide interventional physicians with a single-device, “one-and-done” solution for the occlusion of a wide range of peripheral arterial targets. The LOBO system combines neurovascular-derived HDBRAID technology with a patented design to create a highly occlusive structure for fast and efficient closure of blood vessels throughout the body.
LOBO-5, the second offering in the company’s product portfolio, is intended for use in 3–5mm diameter vessels. LOBO-3, the company’s first occluder, is intended for use in 1.5–3mm 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,” said Bob Rosenbluth, president and CEO of Okami Medical.
He continued: “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.”