Cook Medical’s Zilver Vena venous self-expanding stent has shown high rates of patency sustained for three years, according to recently published data in the Journal of Vascular and Interventional Radiology (JVIR). The patency results extended across all patient subgroups, and patients experienced improvements in clinical scoring as compared to baseline.
“We strive for predictable results and are committed to long-term clinical evidence,” said Alec Cerchiari, a director of product management for Cook Medical’s vascular division. “We also gather insights on how to make our products better and create new medical devices for the future. The results we got from the VIVO study confirmed the safety and effectiveness of our stent in a wide variety of patient types that hadn’t been studied in detail like this before.”
Key three-year study outcomes include:
Sustained patency through three years across all patient groups. The Kaplan-Meier estimates for patency by ultrasound at three years were:
- 90.3% for the overall patient cohort
- 100% for the non-thrombotic iliac vein lesion (NIVL) group
- 84% for the acute deep vein thrombosis (aDVT) group
- 86.1% for the post-thrombotic (PTS) group
Effectiveness was further demonstrated by sustained clinically-driven reintervention rates across all groups. The Kaplan-Meier estimates for clinically-driven reintervention at three years were:
- 92.6% for the overall patient cohort
- 100% for the NIVL group
- 92.1% for the aDVT group
- 87.1% for the PTS group
- No stent fractures through three years, demonstrating stent durability
Positive clinical outcomes for patients which were sustained through three years, demonstrated by improvements in patient symptoms and venous disease scores compared to baseline, specifically scores for venous clinical severity score (VCSS), venous disability score (VDS), chronic venous insufficiency quality of life questionnaire (CIVIQ-20) and clinical, etiological, anatomic, pathophysiology (CEAP) clinical classification (CEAP C classification).
