Limerick, Ireland – Dr. Paul Gagne presented the three-year results of Cook Medical’s VIVO Clinical Study of the Zilver® Vena™ Venous Self-Expanding Stent at the Vascular Interventional Advances (VIVA) 2021 conference. The VIVO Clinical Study represents the first Investigational Device Exemption for a venous stent and enrolled 243 patients considered representative of a real-world population with iliofemoral venous outflow obstruction. The study results met the 1-year endpoints, and the 3-year results support the continued safety and effectiveness of the stent.1
Zilver Vena is a self-expanding stent that Cook Medical designed to meet the needs of patients suffering from symptomatic iliofemoral venous outflow obstruction. When implanted in a patient, Zilver Vena expands to restore venous flow. Main highlights of the study’s three-year data include:
- Patients treated in the VIVO-US study are reflective of a real-world population, including clinical presentations of 105 PTS (43.2%), 79 NIVL (33%), and 59 acute DVT (24%) patients.
- 32.5% of patients had stent extension below the inguinal ligament into the common femoral and/or femoral vein.
- Zilver Vena is associated with a high rate of patency by ultrasound (90.3% ± 2.2%) three years after the initial procedure.
- Patients treated with Zilver Vena demonstrated significant improvement in clinical symptoms as measured by VCSS (venous clinical severity score), VDS (venous disability score), CEAP “C” classification (clinical condition), and CIVIQ (chronic venous insufficiency quality of life). These measures improved significantly (p<0.0001) by 1 month post-procedure, with continued or sustained improvement through 3 years.
- Stent integrity was maintained through 3 years, with no fractures identified by the core laboratory.
“Tracking patient data for three years is difficult, but it’s so important. It gives us insights into the long-term effects of our products and how they shape people’s lives,” said Mark Breedlove, vice president of Cook Medical’s Vascular division. “We are committed to gathering more data to innovate venous therapies and improve the lives of patients with the complex condition of venous disease.”
For more information, visit the Zilver Vena product page here.
Dr. Gagne is a paid consultant of Cook Medical.
Please see product risk information in the IFU at cookmedical.eu.
About Cook Medical
Since 1963, Cook Medical has been inventing, manufacturing and delivering a unique portfolio of medical devices to healthcare systems around the world. We work closely with physicians to develop technologies that improve patients’ lives. Because we remain family owned, we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at CookMedical.eu, and for the latest news, follow us on Twitter, Facebook and LinkedIn.
1 Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (VIVO Clinical Study) IDE #G110228; Global Clinical Study Number: 11-010; 18 May 2020.