Medtronic has received U.S. 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, also known as deep venous obstruction.
Deep venous obstruction occurs when the veins in the deep venous system become obstructed, blocked and/or compressed causing restricted blood flow to the heart. If left untreated, patients can experience leg discomfort and pain, limiting their mobility and quality of life. Symptoms of the disease include leg swelling, skin changes, leg ulcers, and pain. Severe complications can occur, such as blood clots that migrate to the lungs (pulmonary embolism), a clot in the leg called a deep vein thrombosis (DVT), or the formation of fibrotic tissue or scarring caused by a chronic DVT (post thrombotic syndrome).
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).
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, North Carolina "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. 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, the Abre stent system demonstrated a 0% fracture rate in bench testing simulated out to 50 years.
Carolyn Sleeth, vice president and general manager of the endoVenous business, which is part of the Cardiac and Vascular Group at Medtronic, said: "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. We are excited to bring Abre to the U.S. 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.
