Okami Medical, a medical technology company developing novel vascular embolization solutions, announced that the U.S. FDA has granted an expanded indication for its LOBO Vascular Occlusion System. The expanded indication extends the use of LOBO into peripheral veins, broadening embolization options for patients with venous conditions such as pelvic venous disease and portal hypertension.

"The LOBO Vascular Occluder represents the natural evolution of embolization devices - providing fast and predictable occlusion across a wide range of vascular conditions," said Raj Pyne, MD, FSIR of Rochester Regional Health. "Previously in venous embolization, physicians often needed multiple redundant devices, contended with trackability issues, and faced significant CT metallic artifact that obscured follow-up imaging. LOBO's expanded indication brings venous embolization into the next generation, providing quick and confident occlusion with precise placement while minimizing streak artifact on CT, thus simplifying procedures for physicians and follow-up for patients."

The LOBO device is a novel embolization system that gives physicians fast, reliable occlusion with controlled, mechanical precision across a broad range of peripheral vessel anatomies. At its core is Okami's proprietary HDBRAID construction, engineered to optimize deliverability, occlusivity, and stability for efficient procedures.

"In my experience, the LOBO vascular occlusion system has proven to be a rapid and reliable embolization platform," said Harris Chengazi, MD of Great Lakes Medical Imaging. "The venous indication expansion is an exciting frontier, bringing an intuitive and effective device into the paradigm for treating a myriad of venous conditions."

"This venous indication expansion reflects Okami's continued investment in the peripheral embolization space," said Drew Hykes, Chief Executive Officer of Okami Medical. "We look forward to bringing the benefits of LOBO to more patients."