The first offering in the company's product portfolio, LOBO-3, recently received 510(k) clearance from the U.S. Food and Drug Administration for the occlusion of peripheral arteries.
Okami Medical Inc., a medical device company, announced today the successful completion of the first cases with the LOBOTM Vascular Occlusion System.
The first offering in the company’s product portfolio, LOBO-3, recently received 510(k) clearance from the U.S. Food and Drug Administration for the occlusion of peripheral arteries.
The LOBO (LOw-profile Braided Occluder) system is uniquely designed to provide interventional physicians with a single-device, one-and-done solution for the occlusion of various arterial targets without the need for multiple embolic devices.
The LOBO system combines a patented design with proprietary HDBRAIDTM technology to create a highly occlusive pore structure that substantially reduces blood flow and accelerates vessel closure. The LOBO-3 occluder is intended for use in 1.5 to 3 mm diameter vessels.
Dr. Ripal Gandhi, Interventional Radiologist, Miami Cardiac and Vascular Institute, performed the first LOBO-3 implant. “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,” said Dr. Gandhi.
“Guided by world-class physician collaborators, Okami is committed to addressing numerous challenging aspects of peripheral vascular occlusion,” said Bob Rosenbluth, PhD, President and CEO of Okami Medical. “We are very pleased with the clinical performance of the LOBO-3 occluder in the initial cases. The device is in clinical use at key centers and we look forward to expanding our launch in 2020.”
Source: Company Press Release