Okami Medical Receives FDA Expanded Indication for LOBO Vascular Occluder in Peripheral Veins

Okami Medical has announced that the U.S. Food and Drug Administration (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 device is an embolization system designed to provide physicians with fast, reliable occlusion and 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. The expanded venous indication reflects Okami’s continued investment in the peripheral embolization space.

Raj Pyne, MD, FSIR, of Rochester Regional Health, said the LOBO Vascular Occluder represents the natural evolution of embolization devices, providing fast and predictable occlusion across a wide range of vascular conditions. Pyne noted that 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, and that 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, simplifying procedures for physicians and follow-up for patients.

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