Medtronic’s Self-Expanding Venous Stent Gets FDA Clearance
Medtronic has received FDA 510(k) clearance for its Abre venous self-expanding stent system, allowing the device to be used for the treatment for venous outflow obstructions.
The stent system, which is designed to be permanently implanted, is now indicated for use in patients with deep venous obstruction in the iliac or femoral veins, which occurs when the veins become obstructed, blocked or compressed.
The stent “offers patients an alternative to more complex surgical procedures,” Medtronic said. The device received a CE mark certification in April 2017.