Boston Scientific Corporation announces 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, (LINC), in Leipzig, Germany. The VIRTUS trial evaluated the VICI stent in patients with clinically significant obstructions in the illiofemoral venous outflow tract resulting from Post Thrombotic Syndrome (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 84.0% at 12-months, which was greater than the pre-defined performance goal (PGE) of 72.1% (p-value=<0.0001). 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 (PGS) of 94%. The VIRTUS IDE trial, submitted in June of 2018, is a prospective, multi-center, single-arm, non-randomized study that included 170 patients with chronic disease; 75 percent of whom were diagnosed as having post-thrombotic lesions and the remaining 25% were diagnosed with non-thrombotic lesions (i.e., May-Thurner syndrome). The VICI stent system was approved for use in Europe and other geographies that recognize CE Mark in 2013. In the U.S., the VICI stent system is an investigational device and is not available for sale. The device was developed by VENITI Inc., which Boston Scientific acquired in August of 2018.