Okami Medical’s LOBO-7 and LOBO-9 Vascular Occluders Receive FDA Clearance

June 7, 2022—Okami Medical Inc. announced FDA 510(k) clearance of the LOBO-7 and LOBO-9, the latest addition to the company’s LOBO—low-profile braided occluder—vascular occluder system that also includes the LOBO-3 and LOBO-5 devices.

LOBO-7 and LOBO-9 are intended for use in 5- to 7-mm and 7- to 9-mm diameter vessels, respectively. LOBO-3 and LOBO-5, both previously FDA cleared, are intended for use in 1.5- to 3-mm and 3- to 5-mm diameter vessels, respectively.

According to the company, the LOBO system is built for fast and complete occlusion of a diverse set of peripheral arterial targets. The LOBO occluders integrate the company’s HDBraid technology with a design that provide interventional physicians with a one-and-done solution for embolization. The highly occlusive braided structure rapidly reduces flow and enables single-device occlusions of blood vessels throughout the body.

“LOBO represents the next evolution in vascular embolization,” commented Raj Pyne, MD, in the company’s press release. “As opposed to coils, which rely on the formation of an irregular mass with relatively large voids to try to occlude vessels, LOBO utilizes a high density, uniform small pore structure to occlude vessels nearly instantly.”

Dr. Pyne, who is an interventional radiologist at Rochester Regional Health in Rochester, New York, continued, “The ability to occlude vessels quickly and consistently with a single-device not only improves procedure efficiency, but also is critical and often life-saving in situations such as trauma and unstable bleeding. The smaller occluders, LOBO-3 and LOBO-5, have demonstrated excellent performance and I am excited to see the larger sizes in use.”