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FDA Expands Indication for Okami Medical’s LOBO Occlusion System

The U.S. Food and Drug Administration has cleared the LOBO Vascular Occlusion System for use in peripheral veins, marking a strategic expansion for the Aliso Viejo-based company. This regulatory approval allows the device to treat complex venous conditions, including pelvic venous disease and portal hypertension, using its proprietary mechanical design.

FDA Expands Indication for Okami Medical’s LOBO Occlusion System
Photo: Bio & News

Physicians previously relied on multiple redundant devices to address venous conditions, often struggling with poor trackability and metallic artifacts that clouded follow-up CT scans. The LOBO system utilizes a proprietary HDBRAID construction, engineered to provide rapid, predictable occlusion while maintaining stability across diverse vessel anatomies. According to Dr. Raj Pyne of Rochester Regional Health, the device simplifies both the surgical procedure and subsequent patient imaging by minimizing streak artifacts.

Dr. Harris Chengazi of Great Lakes Medical Imaging noted that the system serves as an intuitive platform for treating a broad range of venous pathologies. For Okami Medical, the expansion represents a deliberate push to capture a larger share of the peripheral embolization market. CEO Drew Hykes stated that the company remains focused on scaling the technology to reach more patients, reinforcing their commitment to developing versatile tools for vascular intervention.

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