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December 16, 2020
FDA Clears Okami Medical’s LOBO-5 Vascular Occluder
December 16, 2020—Okami Medical Inc. announced FDA 510(k) clearance of the LOBO-5 vascular occluder system.
According to the company, LOBO is a low-profile, braided occluder system designed as a single-device, “one-and-done” solution for the occlusion of a wide range of peripheral artery targets. The LOBO system combines Okami Medical’s neurovascular-derived HDBraid technology with a design that creates a highly occlusive structure for fast and efficient closure of blood vessels throughout the body.
LOBO-5 is intended for use in 3- to 5-mm diameter vessels. It is the second offering in the company’s product portfolio. In March 2020, the company announced the first cases performed with the LOBO-3, the company’s first occluder, which had recently received FDA 510(k) clearance. LOBO-3 is intended for use in 1.5- to 3-mm diameter vessels.
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