Okami Medical yesterday said it won FDA 510(k) clearance for its LOBO Vascular Occlusion System.
The Low-Profile Braided Occluder (LOBO) system helps patients and physicians with the occlusion of peripheral blood vessels. The system uses HDBraid technology to give physicians a minimally invasive platform for rapid and focal occlusion of a wide range of arterial targets in a single device.
Okami Medical’s LOBO occluder is a low-profile embolic device that features a microcatheter for smooth navigation in the peripheral vasculature. The occluder self-expands when deployed to conform to a range of targets like curved vessels.
The occluder has a dense pore structure that spans the vessel lumen to reduce flow rapidly and accelerate hemostasis. The design enables the technology to create a scaffold for efficient treatment. The single-click mechanical detachment handpiece gives physicians a precise, instant release of the occluder at a target location.
“The FDA clearance, initial U.S. launch and patent issuance mark major milestones in our mission to provide patients and physicians with access to advanced technologies that address numerous challenging aspects of peripheral vascular occlusion,” president and CEO Bob Rosenbluth said in a news release. “The LOBO System is uniquely designed to provide a one-and-done solution for many occlusion targets, thus potentially avoiding the need for several embolic devices and enabling more efficient interventions.”