FDA approves stent system to treat iliofemoral venous obstructive disease

The Food and Drug Administration has approved Boston Scientific’s Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease.

Venous obstructive disease 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.

Dr. Mahmood Razavi, St. Joseph Hospital, Orange, California, said: "For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimised for the disease. With the approval of the VICI stent, clinicians now have access to a stent that was purposely developed and engineered to resist the vessel compression and anatomical tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients."

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 illiofemoral venous outflow tract. It successfully met its primary safety and effectiveness endpoints.

Jeff Mirviss, senior vice president and president, peripheral interventions, Boston Scientific, said: "The FDA approval of the VICI venous stent system is the latest example of our commitment to building the most comprehensive portfolio of technologies specifically developed to meet the needs of physicians treating both chronic and acute venous disease. We are pleased to provide this differentiated stent system to U.S. patients suffering from debilitating deep venous disease."

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