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Medtronic : Venous Stent Receives U.S. FDA Approval to Treat Venous Outflow Obstruction
|10/27/2020 | 08:46am|
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). 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 2.0% (4/200) rate of major adverse events (MAEs) within 30 days.1 The study also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88.0% (162/184).2 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
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. Based on data presented at the Leipzig Interventional Course (LINC) 2020 annual meeting by
'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
Abre received CE (Conformite Europeene) Mark approval in April of 2017 and is also intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
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