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Okami Medical Receives Expanded Indication for the LOBO Vascular Occluder
The expanded indication broadens embolization options for patients with pelvic venous disease and portal hypertension, officials said.
On Wednesday, Oct. 7, 2026, the FDA granted Okami Medical an expanded indication for its LOBO Vascular Occlusion System, allowing use in peripheral veins for conditions like pelvic venous disease.
Engineered with proprietary HDBRAID construction, the LOBO provides fast, predictable occlusion across various vessel anatomies, optimizing deliverability and stability for complex vascular conditions.
Raj Pyne, FSIR of Rochester Regional Health, noted that previous embolization devices often faced "trackability issues" and "significant CT metallic artifact," which the expanded indication helps minimize.
Harris Chengazi of Great Lakes Medical Imaging said, "In my experience, the LOBO has proven to be a rapid and reliable embolization platform," endorsing the system's clinical performance.
Chief Executive Officer Drew Hykes said, "This venous indication expansion reflects Okami's continued investment in the peripheral embolization space," as the company aims to bring benefits to more patients.