Okami Medical, a medical technology company focused on vascular embolisation solutions, has announced the enrolment of the first patient in its ALPHA Registry, a prospective, multicentre clinical study evaluating the LOBO Vascular Occlusion System. The registry aims to assess the safety and effectiveness of the device in treating a range of peripheral vascular conditions, including arterial haemorrhage and pulmonary arteriovenous malformations (PAVMs).

The first procedure was conducted at UMass Memorial Medical Centre, where physicians successfully used the LOBO system to treat multiple PAVMs. The treatment involved deploying one device per feeding artery, achieving intraprocedural vessel occlusion in under two minutes per vessel, demonstrating the device’s efficiency in clinical use.

The LOBO Vascular Occlusion System is designed to provide controlled mechanical occlusion of peripheral blood vessels across diverse anatomical conditions. Built using a proprietary HDBRAID construction, the device enhances deliverability, stability and occlusion performance, enabling physicians to achieve rapid and reliable outcomes during embolization procedures.

Experts involved in the study highlighted the device’s potential to deliver predictable and efficient results across a wide range of vascular conditions. The ALPHA Registry is structured to capture detailed clinical outcomes across multiple indications, offering insights that could help refine treatment approaches and improve patient care in embolisation therapies.

The registry forms a key part of Okami Medical’s broader clinical strategy to generate real-world evidence supporting the LOBO system. The study plans to enrol up to 500 patients across as many as 30 clinical sites, contributing to the growing body of data on advanced vascular occlusion technologies.

With this milestone, Okami Medical aims to strengthen the clinical validation of its innovative embolization platform and expand its application in the treatment of complex vascular disorders.