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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.
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Okami Medical Receives Expanded Indication for the LOBO Vascular Occluder

ALISO VIEJO, Calif., Oct. 7, 2026 /PRNewswire/ -- Okami Medical, a medical technology company developing novel vascular embolization solutions, announced today that the U.S. FDA has granted an expanded indication for its LOBO® Vascular Occlusion System. The expanded indication extends…

·Billings, United States
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Helena Independent Record broke the news in Helena, United States on Wednesday, October 7, 2026.
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