Okami Medical, Inc. issued the following announcement on Nov. 4.
Okami Medical Inc., a medical device company, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and initial launch of the LOBOTM Vascular Occlusion System.
The Company further announced that U.S. Patent No. 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 hemostasis. 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 U.S. 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, PhD, 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 U.S. launch of the LOBO system will be limited.
About Okami Medical
Okami Medical, Inc. is a privately-held medical device company with a mission to address the evolving needs of patients and physicians through the development of innovative, versatile, and intuitive devices for the occlusion of peripheral vessels. The company was founded in 2017 by Inceptus Medical, a medical device incubator. Okami is backed by members of the board of directors, U.S. Venture Partners (USVP) and medical device industry veterans.
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