ABK Biomedical’s EasiVue Embolic Microspheres Gain 510(k) Clearance
ABK Biomedical’s EasiVue embolic microspheres were cleared by the FDA for the treatment of patients with arteriovenous malformations and hypervascular tumors.
Hypervascular tumors, which can be benign or malignant, are characterized by blood supply from an abnormally large number of blood vessels. The device, which reduces or eliminates the blood flow to these tumors, is a tiny hollow tube fitted into a tumor’s feeding artery. It’s radiopaque, meaning opaque to X-rays or similar radiation, and allows for direct visualization at the target site.
Arteriovenous malformations occur when capillaries, veins and arteries don't develop properly. The condition may lead to cutaneous discoloration, sensitivity, pain, and vascular bleeding.
Additionally, ABK is developing radio-embolic technology for the treatment of patients with unresectable hepatic cellular carcinoma (HCC).