Bloomington, Ind. — 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).1 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 3 years were:
- 90.3% for the overall patient cohort
- 100% for the NIVL (nonthrombotic iliac vein lesion) group
- 84% for the aDVT (acute deep vein thrombosis) group
- 86.1% for the PTS (post thrombotic) group
- Effectiveness was further demonstrated by sustained clinically-driven reintervention rates across all groups. The Kaplan-Meier estimates for clinically-driven reintervention at 3 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 3 years, demonstrating stent durability
- Positive clinical outcomes for patients which were sustained through 3 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)
About the VIVO clinical trial
The VIVO clinical study 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 study included represented a real-world population, including a total of 243 patients with obstruction originating from obstructive lesions after removal of acute DVT (aDVT; n=58), post-thrombotic syndrome (PTS; n=105), and non-thrombotic iliac vein obstruction (NIVL; n=79).
You can read details about the VIVO data in this JVIR publication. For more resources about Zilver Vena, including a product animation and a reimbursement analysis, visit the product page on our website.
About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we invent, manufacture and deliver a unique portfolio of medical devices to the healthcare systems of the world. Serving patients is a privilege, and we demand the highest standards of quality, ethics and service. We have remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.
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[1] Comerota, A. J., Gagne, P., Brown, J. A., Segbefia, E., Hofmann, L. V., & VIVO Clinical Study Investigators. (2024). Final 3-Year Study Outcomes from the Evaluation of the Zilver Vena Venous Stent for the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (The VIVO Clinical Study). Journal of Vascular and Interventional Radiology, 35(6), 834-845.
