Boston Scientific has 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.

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Image: Boston Scientific's SYNERGY Bioabsorbable Polymer Stent System. Photo: Courtesy of Boston Scientific Corporation.

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 percent at 12-months, which was greater than the pre-defined performance goal (PGE) of 72.1 percent (p-value=<0.0001). Nearly all the patients treated with the VICI stent, 98.8 percent, were free from major adverse events at 30 days post-procedure, thus surpassing the pre-defined safety performance goal (PGS) of 94 percent.

“In treating patients with venous obstruction, the primary goal is to restore and maintain vessel patency to ensure the return of blood flow to the heart,” said Dr. Mahmood Razavi, Director, Department of Clinical Trials, St. Joseph Heart and Vascular Center, Orange, California and principal investigator of the VIRTUS trial. “In these results, the VICI stent demonstrated excellent performance outcomes in a difficult-to-treat patient population, which translates to improvement of long-term symptoms and enhanced quality of life in these patients.”

“Physicians who select endovascular treatment options for their patients with venous disease are not only faced with challenging disease-states but must also account for the unique anatomical presentation of these deep veins that are subject to chronic obstruction and compression,” said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific. “The results from the VIRTUS trial demonstrate the importance of having a therapeutic option that is specifically designed for venous application, thus helping patients avoid recurrent pain, swelling and other debilitating aspects of acute and chronic venous disease.”

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 percent 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.

Source: Company Press Release