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March 2, 2014

Cook Medical Begins VIVO Study of Zilver Vena to Treat Iliofemoral Venous Outflow Obstruction

March 3, 2014—Cook Medical (Bloomington, IN) announced the commencement of the VIVO clinical study, which is designed to evaluate the safety and effectiveness of treating symptomatic iliofemoral venous outflow obstruction with Cook Medical’s Zilver Vena venous self-expanding stent. The Zilver Vena stent is an investigational device that is not approved for sale in the United States, advised the company.

The first ten patients have been enrolled in the trial and are undergoing treatment at six healthcare facilities in the East Coast and Midwest of the United States. Charles B. Ross, MD, Chief of Vascular and Endovascular Services at Piedmont Heart Institute in Atlanta, Georgia, was the first physician to enroll a patient in the study.

In Cook Medical’s press release, Dr. Ross commented, “I am overjoyed to be part of a trial specifically designed to address iliofemoral venous outflow obstruction with a stent designed for this purpose. With the Zilver Vena stent and VIVO trial, we enter a new and exciting era. I feel privileged to participate.”

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March 3, 2014

FDA Seeks Comments on Draft Guidance Document Addressing the Distribution of Information on Nonapproved Uses of Drugs and Devices

March 3, 2014

FDA Seeks Comments on Draft Guidance Document Addressing the Distribution of Information on Nonapproved Uses of Drugs and Devices


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