www.fdanews.com/articles/193318-fda-clears-okamis-vascular-occlusion-system
FDA Clears Okami’s Vascular Occlusion System
November 4, 2019
The FDA granted Okami Medical 510(k) clearance for its Lobo vascular occlusion system, a device used in the occlusion of peripheral blood vessels.
The low-profile braided occluder is a minimally invasive device for rapid and focal occlusion of a wide range of arterial targets.
The system is compatible with microcatheters, allowing it to navigate the peripheral vasculature. It self-expands upon deployment and can conform to multiple targets, including curved vessels.