Medtronic this week announced that it received FDA approval for its Abre venous self-expanding stent system.
The device is indicated for use in the iliofemoral veins in patients that have symptomatic iliofemoral venous outflow obstruction.
“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, global principal investigator for the ABRE clinical study, said in a news 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.”
Abre is intended for the permanent implant and uses an open-cell design with three offset connection points for flexibility and stability during deployment.
“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, VP and GM of the endoVenous business at Medtronic, said. “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.”
Medtronic’s Abre won CE Mark approval in April 2017 and is intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.