October 27, 2020 – Medtronic plc (Dublin, Ireland) received U.S. Food and Drug Administration (FDA) approval for the Abre venous self-expanding stent system.
The device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction, also known as deep venous obstruction.
A self-expanding stent system, Abre is intended for permanent implant and utilizes an open-cell design with three off-set connection points to enable flexibility and stability during deployment. Abre also offers a balance of strength, flexibility, and fatigue resistance, the company says.
The FDA approval is based on 12-month results from the ABRE clinical study. The ABRE study assessed the safety and effectiveness of the investigational Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with post thrombotic syndrome, non-thrombotic iliac vein lesions (NIVL), and those who presented with an acute deep vein thrombosis (aDVT).
The study met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88% (162/184). Despite the challenging patient population, no stent fractures and no stent migrations were reported in the study.
Abre received CE Mark approval in April of 2017 and is intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.