The trial intends to assess the safety and effectiveness of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
The VIVO clinical study is an FDA-approved investigational device exemption (IDE) trial, which is being conducted in the US.
Cook Medical has recruited 243 patients with acute or chronic symptomatic iliofemoral venous outflow obstruction in the study.
With a one-year primary endpoint, the trial is being carried out in 29 active sites across the US and one center in Taiwan.
Recently, the firm completed a similar study in the European Union to evaluate the safety and efficacy of the Zilver Vena stent.
Cook Medical peripheral intervention clinical division global leader and vice president Mark Breedlove said: “This is an area of medicine with few treatment options. In fact, there is no FDA-approved venous stent to treat this painful condition.
“It is our mission to become a valued partner in the treatment of symptomatic iliofemoral venous obstruction.”
In September, the company launched Zilver PTX drug-eluting peripheral stent thumbwheel delivery system in France.
The rotating thumbwheel system, which is available for purchase in approved markets across Europe, provides deployment for the world’s first drug-eluting stent for the superficial femoral artery.
