Self-expanding stent to treat venous outflow obstruction gains FDA approval
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Medtronic announced it received FDA approval for its venous self-expanding stent system, indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction.
The self-expanding stent system (Abre, Medtronic) is intended for permanent implantation and utilizes an open-cell design with three offset connection points to enable flexibility and stability during deployment, according to a press release from the company.
"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," Erin Murphy, MD, FACS, director of Atrium Health Sanger Heart & Vascular Institute's Venous and Lymphatic Program in Charlotte, North Carolina, said in the release. "With FDA approval, we now have this important tool in our arsenal to treat patients with even the most challenging of deep venous lesions."
According to the release, the ABRE clinical study, presented in June at the Charing Cross Symposium, met its primary safety endpoint with a 2% rate of major adverse events at 30 days and also met its 12-month primary effectiveness endpoint with an overall primary patency rate of 88%.
Based on data presented at the Leipzig Interventional Course in February, the self-expanding stent system demonstrated a 0% fracture rate in bench testing simulated out to 50 years, according to the release.
"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," Carolyn Sleeth, vice president and general manager of the endoVenous business, which is part of the Cardiac and Vascular Group at Medtronic, said in the release. "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."
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