Boston Scientific announces Vici stent meets primary endpoint in VIRTUS trial
Boston Scientific announced positive 12-month data demonstrating that patients who were treated with the Vici Venous Stent System for iliac and femoral vein obstructions exhibited a high rate of patent, or open, target lesions. Primary safety and efficacy results from the VIRTUS trial were presented as a first-time data release at the Leipzig Interventional Course, or LINC. The VIRTUS trial evaluated the Vici stent in patients with clinically significant obstructions in the illiofemoral venous outflow tract resulting from Post Thrombotic Syndrome, or PTS, or compressive diseases such as May-Thurner syndrome. These conditions impact the veins located deep in the pelvis and if left untreated, can impair blood flow back to the heart and cause blood to pool in the legs, resulting in pain, swelling and ulceration. In the VIRTUS trial, the Vici stent met its primary effectiveness endpoint with a primary patency rate of 84% at 12-months, which was greater than the pre-defined performance goal, or PGE, of 72.1%. Nearly all the patients treated with the VICI stent, 98.8%, were free from major adverse events at 30 days post-procedure, thus surpassing the pre-defined safety performance goal of 94%.