Vascular Occlusion System Gains Expanded FDA Indication for Venous Embolization

Venous embolization is used in peripheral veins for conditions including pelvic venous disease and portal hypertension. Physicians have faced procedure-related challenges, including the need for multiple redundant devices, trackability issues, and CT metallic artifact that can obscure follow-up imaging. A newly expanded indication now extends a vascular occlusion technology into peripheral veins, broadening embolization options for these patients.

Okami Medical (Aliso Viejo, CA, USA) has received an expanded indication from the U.S. Food and Drug Administration (FDA) for the LOBO Vascular Occlusion System. The expanded indication extends use of LOBO into peripheral veins. The device is intended to broaden embolization options for patients with venous conditions such as pelvic venous disease and portal hypertension.

LOBO is a vascular occlusion system designed to provide occlusion with controlled mechanical precision across a range of peripheral vessel anatomies. The system is based on Okami’s proprietary HDBRAID construction. This design is engineered to support deliverability, occlusivity, and stability during procedures.

The expanded indication addresses clinical workflow challenges described for venous embolization procedures. These include the previous need for multiple devices, difficulties with trackability, and CT metallic artifact that could interfere with follow-up imaging. The system is described as supporting precise placement while minimizing streak artifact on CT.

Okami Medical is a privately held medical device company focused on devices for the occlusion of peripheral vessels. The venous indication expansion reflects the company’s continued activity in the peripheral embolization space. The company said it expects the expanded indication to make LOBO available to more patients.

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