VIVO-EU Evaluates Cook Medical's Zilver Vena Stent

September 29, 2015—Cook Medical announced the presentation of preliminary results from the company’s VIVO-EU study of the Zilver Vena self-expanding venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction. VIVO-EU is a European, prospective, multicenter nonrandomized study. 

Gerard O’Sullivan, MD, presented interim study results at CIRSE 2015, the Cardiovascular and Interventional Radiological Society of Europe annual meeting held September 26–30 in Lisbon, Portugal. Dr. O’Sullivan is principal investigator of the VIVO-EU study at the University Hospital Galway, Ireland.

According to Cook Medical, VIVO-EU enrolled 35 patients with symptomatic iliofemoral outflow obstruction. These patients had leg pain that limited usual activity, swelling, or skin discoloration in the leg. The study has reached full enrollment and three-quarters of patients have been followed for 6 months or longer. Patients will be followed to monitor complication rates and improvement of symptoms. 

The study investigators reported that all Zilver Vena stents deployed as intended, and no stent was scored as difficult to deploy. Stent placement periprocedurally resulted in a more than two-fold improvement in the vessel minimum lumen diameter. Based on available follow-up data, stent placement has corresponded to improved clinical symptoms, stated Cook Medical.