Final patient enrolled for iliofemoral venous stent study

Zilver venous stent

Cook Medical has completed enrolment in the first clinical study of an iliofemoral venous stent conducted in the USA under an FDA-approved investigational device exemption. The VIVO clinical study is a prospective, non-randomised, multicentre study intended to evaluate the safety and effectiveness of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

A total of 243 patients with acute or chronic symptomatic iliofemoral venous outflow obstruction were enrolled in the VIVO Clinical Study, which has a one-year primary endpoint. The study is being conducted in 29 active sites throughout the US as well as one in Taiwan. A press release reports that Cook Medical recently completed a similar first-of-its-kind study in the European Union on the safety and performance of the Zilver Vena stent. Gerard O’Sullivan (Galway University Hospitals, Galway, Ireland) will present data from the VIVO-EU study on Friday at the 2016 VEITHsymposium (15–19 November, New York, USA).

Anthony Comerota (Jobst Vascular Institute, Toledo, USA), one of the study’s principal investigators, comments: “I view the completion of enrolment for this trial as an important milestone in development of options for managing patients with proximal venous obstruction. I am excited to see the full enrollment of the first FDA-approved venous stent trial.”

“This has the opportunity to help many patients,” agreed Lawrence “Rusty” Hofmann (Stanford University Hospital, Stanford, USA), co-principal investigator, agreed.