Enrollment Complete in IDE Study for Medtronic's Abre Venous Stent
January 31, 2019—Medtronic recently completed enrollment of its investigational device exemption (IDE) study of the Abre venous self-expanding stent system. The study, which began enrollment 1 year ago, is evaluating the safety and effectiveness of the Abre stent in patients with iliofemoral venous outflow obstruction.
According to the company, data from the study will be used to support the FDA premarket approval application for the Abre stent for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease. Currently, Abre is an investigational device in the United States. In Europe, the device received CE Mark approval in April 2017.
The Abre stent is intended for permanent implant in the iliofemoral vein. The nitinol stent is premounted on a 9-F delivery system with a triaxial shaft design. The stent utilizes an open-cell design with three connection points between the cells that are intended to enable flexibility and conformability. When deployed, the Abre stent uses a balance of strength and flexibility to exert an outward force and open the vein, stated Medtronic.
Medtronic noted that Abre is the company's first stent designed for use in patients with iliofemoral venous outflow obstruction, marking a milestone in the company’s goal to provide new options for the treatment of deep venous disease.