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October 8, 2026

Okami Medical Receives Expanded Indication for LOBO Vascular Occluder

KEY TAKEAWAYS

  • The FDA has expanded the indication for Okami Medical’s LOBO vascular occlusion system to include peripheral venous embolization.
  • The expanded indication encompasses venous applications, including conditions such as pelvic venous disease and portal hypertension.
  • The device incorporates HDBraid technology designed to support deliverability, vessel occlusion, and device stability.

October 8, 2026—Okami Medical announced that the FDA has granted an expanded indication for its LOBO vascular occlusion system. The expanded indication extends the use of LOBO into peripheral veins, offering embolization options for patients with venous conditions such as pelvic venous disease and portal hypertension, stated the company.

Okami noted that the LOBO device features the company’s HDBraid construction, which is engineered to optimize deliverability, occlusivity, and stability for efficient procedures.

Raj Pyne, MD, and Harris Chengazi, MD, commented on the expanded indication for the LOBO device in the company’s press release. Dr. Pyne is with Rochester Regional Health in Rochester, New York, and Dr. Chengazi is with Great Lakes Medical Imaging in Williamsville, New York.

“The LOBO vascular occluder represents the natural evolution of embolization devices—providing fast and predictable occlusion across a wide range of vascular conditions,” stated Dr. Pyne. “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.”

Dr. Chengazi added, “In my experience, the LOBO vascular occlusion system has proven to be a rapid and reliable embolization platform. The venous indication expansion is an exciting frontier, bringing an intuitive and effective device into the paradigm for treating a myriad of venous conditions.”

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