Cook’s Zilver Vena Stent Shows Sustained High Patency in 3-Year VIVO Study Results

October 29, 2024—Cook Medical announced that findings from the VIVO clinical study of the company’s Zilver Vena venous self-expanding stent demonstrated high rates of patency sustained for 3 years. The patency results extended across all patient subgroups, and patients experienced improvements in clinical scoring as compared to baseline, stated the company.

The VIVO data were published by Anthony J. Comerota, MD, et al in Journal of Vascular and Interventional Radiology (2024;35:834-845).

According to Cook, VIVO is a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the Zilver Vena venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction.

The company noted that the study represented a real-world population, including a total of 243 patients with obstruction originating from obstructive lesions after removal of acute deep vein thrombosis (aDVT; n = 58), post-thrombotic syndrome (PTS; n = 105), and nonthrombotic iliac vein obstruction (NIVL; n = 79).

As outlined in Cook’s press release, key 3-year outcomes from VIVO include the following:

• Sustained patency across all patient groups. The Kaplan-Meier estimates for patency by ultrasound were 90.3% for the overall patient cohort; 100% for the NIVL group; 84% for the aDVT group; and 86.1% for the PTS group.
• Effectiveness was further demonstrated by sustained clinically driven reintervention rates across all groups with Kaplan-Meier estimates were 92.6% for the overall patient cohort;100% for the NIVL group; 92.1% for the aDVT group; and 87.1% for the PTS group.
• No stent fractures, demonstrating stent durability.

Additionally, the sustained positive clinical outcomes were demonstrated by improvements from baseline in patient symptoms and venous disease scores including, the Venous Clinical Severity Score; Venous Disability Score; Chronic Venous Insufficiency Quality of Life questionnaire; and Clinical, Etiological, Anatomic, Pathophysiology clinical classification, noted the company.