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June 8, 2022

Okami Medical secures FDA 510k clearance for vascular occluders

LOBO-7 and LOBO-9 are intended for use in 5mm to 7mm and 7mm to 9mm diameter vessels, respectively.

Okami Medical has received 510k clearance from the US Food and Drug Administration (FDA) for the LOBO-7 and LOBO-9 Vascular Occluders, which address a wide range of peripheral embolization cases.

LOBO-7 and LOBO-9 are the latest addition to the LOw-Profile Braided Occluder (LOBO) system and are intended for use in 5mm to 7mm and 7mm to 9mm diameter vessels, respectively.

Purpose-built for rapid and complete occlusion of a range of peripheral arterial targets, the system now includes LOBO-3, LOBO-5, LOBO-7 and LOBO-9.

It has been designed to block or reduce the blood flow rate in arteries of the peripheral vasculature.

Integrated with patented HDBRAID technology and an innovative design, the LOBO occluders are intended to provide a one-and-done solution for embolization to interventional physicians.

Previously cleared by the FDA, LOBO-3 is designed for use in 1.5mm to 3mm diameter vessels while LOBO-5 is used in 3mm to 5mm diameter vessels.

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.”

The company stated that the highly occlusive braided structure of the LOBO system quickly reduces the blood flow and enables single-device occlusions of blood vessels throughout the body.

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