USFDA clears Boston’s Vici venous stents

July 4, 2019 0 By FM

Bston Scientific said the US FDA has approved the Vici venous stent system for the treatment of iliofemoral venous obstructive disease.

The disease occurs when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies.

The approval of the Vici stent was based on data from the VIRTUS study, a prospective, multi-centre, single-arm study with 170 patients.

The VIRTUS study evaluated the Vici stent in relation to pre-defined objective performance goals in patients with a clinically significant obstruction in the iliofemoral venous outflow tract. It successfully met its primary safety and effectiveness endpoints.

Endovascular treatment for venous obstructive disease is focused on restoring the normal flow of blood from the legs back to the heart.

The iliofemoral veins are located deep in the pelvis and may be subject to significant crushing forces from other anatomical structures such as the right common iliac artery. To help solve for this, the VICI stent system was specifically designed to be uniformly strong and crush resistant, capable of restoring blood flow by creating a cylindrical, patent vessel, Boston scientific said.

The VICI stent system received CE Mark in 2013. The device was developed by Veniti Inc., which Boston Scientific acquired in August of 2018.