logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Beyond Meat Inc. (BYND), the meatless burger and sausage maker, announced the appointment of Sanjay Shah as Chief Operating Officer. Shah will assume the responsibility for Beyond Meat's global operations and production, effective September 18. "It is with great enthusiasm that I welcome Sanjay... A federal court has sentenced the former President of drug compounding company Pharmakon Pharmaceuticals Inc. to prison for defrauding the U.S. Food and Drug Administration and distributing adulterated drugs, the U.S. Department of Justice said. District Judge James Sweeney sentenced Paul Elmer, 68, the former president and owner of Pharmakon Pharmaceuticals Inc. to 33 months in prison. Amazon on Thursday unveiled its ambitious plans to combat climate change, with the announcement coming just a day before its employees plan to walk out of the Seattle headquarters to protest the e-commerce giant's climate policies. The company said it has co-founded the Climate Pledge, a plan to make companies carbon neutral by 2040 and reach the goal of the Paris Accord ten years early.
Follow RTT
>