Okami Medical announces FDA 510(k) clearance and patent for the LOBO vascular occluder

Okami Medical today announced 510(k) clearance by the US Food and Drug Administration (FDA) and initial launch of the LOBO vascular occlusion system.

The company further announced that US patent number 10,376,267, entitled Vascular Occlusion Device and Methods, has been issued by the United States Patent and Trademark Office. The patent, licensed from Inceptus Medical LLC, includes 19 claims that provide key protection for the LOBO system.

Okami developed the LOBO (LOw-profile Braided Occluder) system to address the evolving needs of patients and physicians for the occlusion of peripheral blood vessels. Many peripheral vascular clinical conditions require the safe, effective, and efficient closure of difficult-to-access vessels for successful treatment. The LOBO system combines a patented design with proprietary HDBRAID technology to provide interventional physicians with a minimally invasive platform for rapid and focal occlusion of a wide range of arterial targets with a single device.

The LOBO occluder is a low-profile embolic device that is microcatheter compatible for smooth navigation throughout the peripheral vasculature. The versatile occluder self-expands when deployed, conforming to a range of targets, including curved vessels. Made with HDBRAID technology, the LOBO occluder provides a dense pore structure that spans the vessel lumen to rapidly reduce flow and accelerate haemostasis. The multiple-disk design compounds the occlusive effects of the HDBRAID technology, creating a scaffold for efficient treatment. The intuitive, single-click mechanical detachment handpiece allows for precise, instant release of the occluder at a target location.

“The FDA clearance, initial US launch, and patent issuance mark major milestones in our mission to provide patients and physicians with access to advanced technologies that address numerous challenging aspects of peripheral vascular occlusion,” said Bob Rosenbluth, president and CEO of Okami Medical. “The LOBO system is uniquely designed to provide a one-and-done solution for many occlusion targets, thus potentially avoiding the need for several embolic devices and enabling more efficient interventions.”

The Okami team brings more than a decade of leadership in braiding technology and minimally invasive vascular solutions. The initial US launch of the LOBO system will be limited.