First Cases Performed With Okami Medical’s LOBO-3 Vascular Occluder After FDA Clearance

March 5, 2020—Okami Medical Inc. announced the successful completion of the first cases with the company’s LOBO-3 vascular occlusion system, which recently received FDA 510(k) clearance for the occlusion of peripheral arteries. The device is the first offering in the company’s product portfolio. The device is in clinical use at key centers, with an expanded launch to be conducted in 2020, advised Okami.

According to the company, the LOBO low-profile braided occluder system is designed to provide interventional physicians with a single-device solution for the occlusion of various arterial targets without the need for multiple embolic devices. The microcatheter-delivered device provides fast and focal occlusion of peripheral arterial targets.

The LOBO system incorporates the company’s HDBraid technology to create an occlusive pore structure that reduces blood flow and accelerates vessel closure. The LOBO-3 occluder is intended for use in 1.5- to 3-mm-diameter vessels.

The first LOBO-3 implantation was performed by Ripal Gandhi, MD, an interventional radiologist at Miami Cardiac and Vascular Institute in Miami, Florida. Dr. Gandhi commented in the company’s announcement, “We have successfully utilized the LOBO-3 occluder to embolize several small vessels via a microcatheter. The device has resulted in immediate occlusion of the target vessels. The device tracks well and deploys precisely at the desired location. The LOBO-3 occluder is a great addition to the embolic armamentarium for the occlusion of small vessels.”