Vici Venous Stent Receives FDA Approval for Iliofemoral Obstructive Disease
The self-expanding nitinol stent now joins Venovo as only the second dedicated venous device on the US market.
The US Food and Drug Administration has approved the Vici stent for use in treating iliofemoral venous obstructive disease, Boston Scientific announced today. This is the second approval this year for a dedicated venous stent for a disease that has typically been managed in the past with off-label device use.
The Vici approval was supported by data from the 170-patient VIRTUS study. As reported by TCTMD earlier this year at ISET 2019, VIRTUS demonstrated a 12-month primary patency rate of 84%, exceeding the performance goal of 72.1% (P < 0.001). Additionally, the Venous Clinical Severity Score (VCSS) declined from 10 at baseline to 5.6 at 12 months, with only 27.3% of patients having a score of 8 or higher.
Vici joins the Venovo (Becton Dickinson) device, which received FDA approval for a similar indication less than 2 months ago based on favorable results from the VERNACULAR trial. As reported by TCTMD at VIVA 2018, VERNACULAR demonstrated a high rate of primary patency at 12 months (88.3%) and was associated with sustained improvements in quality of life.
Previously, the Vici stent had received CE Mark in 2013 and the Venovo in 2015.
According to Boston Scientific, venous obstructive disease affects nearly 40% of the US population and is typically caused deep vein thrombosis, postthrombotic syndrome, and compressive diseases such as May-Thurner syndrome. The device is “designed to be crush resistant to meet the unique challenges of venous anatomy, which are subject to directional forces or twisting due to their location deep in the pelvis,” a press release reads.