Medtronic today announced it has received US Food and Drug Administration (FDA) approval for the Abre venous self-expanding stent system. This device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction.
The FDA approval is based on 12-month results from the ABRE clinical study, presented at the 2020 Charing Cross Symposium. 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 also included a challenging patient population, 44% (88/200) of whom required stents that extended below the inguinal ligament into the common femoral vein (CFV). The study met its primary safety endpoint with a 2% (4/200) rate of major adverse events (MAEs) within 30 days. The study also 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.
“Patients with deep venous obstruction are often younger, therefore it’s critical to have a venous stent that is not only safe and effective, but also strong and flexible,” said Erin Murphy, global principal investigator for the ABRE clinical study and director of Atrium Health Sanger Heart & Vascular Institute’s Venous and Lymphatic Program in Charlotte, USA. “With FDA approval, we now have this important tool in our arsenal to treat patients with even the most challenging of deep venous lesions.”
A self-expanding stent system, Abre is intended for permanent implant and utilises an open-cell design with three off-set connection points to enable flexibility and stability during deployment. Based on data presented at the Leipzig Interventional Course (LINC) 2020 annual meeting by Stephen Black, consultant and vascular surgeon, Guy’s, and St Thomas’ Hospital and Kings College in London, UK, the Abre stent system demonstrated a 0% fracture rate in bench testing simulated out to 50 years.
“With Abre, our goal was to create a dedicated venous stent that combined a balance of the key characteristics necessary to treat patients with a broad spectrum of deep venous obstruction,” said Carolyn Sleeth, vice president and general manager of the endoVenous business, which is part of the Cardiac and Vascular Group at Medtronic. “We are excited to bring Abre to the US market, which we believe will provide both physicians and patients with a new option backed by clinical evidence to treat this disease safely and effectively.”
Abre received CE mark approval in April of 2017 and is also intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.