Cook Medical’s Zilver Vena Iliofemoral Stent IDE Study Completes Enrollment
November 15, 2016–Cook Medical announced that it has completed enrollment for its VIVO clinical study, the first such study in the United States to evaluate an iliofemoral venous stent. The VIVO clinical study is intended to assess the safety and effectiveness of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction. The study is being conducted under a US Food and Drug Administration–approved investigational device exemption.
“I view the completion of enrollment for this trial as an important milestone in development of options for managing patients with proximal venous obstruction,” commented Anthony Comerota, MD, one of the Principal Investigators of the study and Executive Director of Research at ProMedica and Jobst Vascular Institute.
The VIVO clinical study has enrolled 243 patients with acute or chronic symptomatic iliofemoral venous outflow obstruction and has a 1-year primary endpoint. It is a prospective, nonrandomized, multicenter study being conducted across 29 active sites throughout the United States, as well as one in Taiwan.
Cook Medical recently completed VIVO EU, a similar safety and performance study of the Zilver Vena stent in the European Union. The findings from that study will be presented at the VEITHsymposium in New York City on November 18.