Boston Scientific’s VICI Venous Stent Approved

FDA has approved a Boston Scientific PMA for the VICI Venous Stent System for treating iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies. The iliofemoral veins often endure “crushing forces from other anatomical structures such as the right common iliac artery,” the company says. “To help solve for this, the VICI stent system was specifically designed to be uniformly strong and crush resistant, capable of restoring blood blow by creating a cylindrical, patent vessel.”

Approval was based on data from the VIRTUS study, which evaluated the VICI stent in relation to pre-defined objective performance goals in patients with a clinically significant obstruction in the illiofemoral venous outflow tract. The study met its primary safety and effectiveness endpoints, according to Boston Scientific.