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Boston Scientific Says VICI VENOUS STENT System Approved By U.S. FDA

Medical devices maker Boston Scientific Corp. (BSX) announced Monday that the U.S Food and Drug Administration (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.

It affects nearly 40 percent of the population in the U.S. and can be caused by conditions such as deep vein thrombosis (DVT), post-thrombotic syndrome (PTS) and compressive diseases such as May-Thurner syndrome. In patients with venous obstructions, blood may pool in the legs, resulting in pain, swelling and skin ulcers.

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 blow by creating a cylindrical, patent vessel.

The approval of the VICI stent was based on data from the VIRTUS study, a prospective, multi-center, 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 illiofemoral venous outflow tract. It successfully met its primary safety and effectiveness endpoints.

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

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