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September 29th, 2015

Preliminary European results announced: Zilver® Vena™ self-expanding venous stent

Lisbon, Portugal – Dr Gerard O’Sullivan announced preliminary results from a European study of venous stents today at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2015, a European meeting for interventional radiologists and vascular specialists. Dr O’Sullivan is the principal investigator of the VIVO-EU study at the University Hospital Galway.

Titled “An Update on VIVO-EU, a Prospective Study of the Zilver Vena Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction,” Dr O’Sullivan’s talk focused on the interim study results. The study has reached full enrolment and three-quarters of patients have been followed for six months or longer.

Thirty-five (35) patients with symptomatic iliofemoral outflow obstruction were enrolled into the study. These patients had leg pain that limited their usual activity, swelling or skin discoloration in their leg. Study physicians reported that all stents deployed as intended and no stent was scored as difficult to deploy. At procedure, Zilver Vena stent placement 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.

“This is the first venous stent trial using a stent designed for the rigours of venous disease,” said Mark Breedlove, vice president of Cook Medical’s Peripheral Intervention division  “It shows why venous stenting is an important part of treating venous disease.”

Evaluation of the Zilver Vena Venous Stent (VIVO EU) is a prospective, non-randomized, multi-centre study intended to evaluate the Zilver Vena stent in the treatment of symptomatic iliofemoral venous outflow obstruction. Patients involved in the study will be followed after their procedure to monitor complication rates and improvement of symptoms.

Dr O’Sullivan, a principal investigator for the VIVO EU trial, is a paid consultant of Cook Medical.

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