US-based medical device company Okami Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its LOBO-7 and LOBO-9 Vascular Occluders.
The new vascular occluders form the latest addition to the company’s LOBO (Low-profile Braided Occluder) Vascular Occlusion System.
Okami’s LOBO system was specifically designed for rapid and complete occlusion of various peripheral arterial targets, and now includes LOBO-3, LOBO-5, LOBO-7 and LOBO-9 vascular occluders.
The occluders combine the patented HDBRAID technology with an advanced design to provide interventional physicians with a single solution for embolisation.
Their highly occlusive braided structure rapidly reduces flow and enables single-device occlusions of blood vessels throughout the body, said the company.
Okami Medical president and CEO Bob Rosenbluth said: “The FDA clearance of LOBO-7 and LOBO-9 is a testament to Okami Medical’s commitment to provide patients and physicians with access to advanced technologies that address the numerous challenges in peripheral vascular occlusion.
“The LOBO system now includes a portfolio of devices that is specifically designed and built to quickly and completely occlude a wide range of vascular targets, thus eliminating the need for multiple embolic devices and enabling more efficient interventions.”
Unlike coils, which depend on the formation of an irregular mass with relatively large voids to occlude vessels, the LOBO system is said to use a high density, uniform small pore structure to occlude vessels.
The LOBO-7 occluder is intended for use in 5mm to 7mm, while the LOBO-9 occluder is intended for 7mm to 9mm diameter vessels.
The LOBO-3 and LOBO-5 were previously granted FDA approval, and are intended for use in 1.5mm to 3mm and 3mm to 5mm diameter vessels, respectively.
Okami Medical is focused on developing advanced solutions to address important unmet clinical needs in peripheral vascular intervention.
It is the second portfolio company of medical device incubator Inceptus Medical, following Inari Medical, which is focused on pulmonary embolism and venous clotting.
