Final Patient Enrolled for Iliofemoral Venous Stent Study

BLOOMINGTON, Ind.–(BUSINESS WIRE)– Cook Medical has completed enrollment in the first clinical study of an
iliofemoral venous stent conducted in the United States under an
FDA-approved Investigational Device Exemption (IDE).

The VIVO Clinical Study is a prospective, non-randomized, multi-center
study intended to evaluate the safety and effectiveness of the Zilver®
Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous
outflow obstruction.

“I view the completion of enrollment for this trial as an important
milestone in development of options for managing patients with proximal
venous obstruction,” said one of the study’s principal investigators,
Dr. Anthony Comerota, Jobst Vascular Institute.

Dr. Lawrence “Rusty” Hofmann, co-principal investigator from Stanford
University Hospital, agreed. “I am excited to see the full enrollment of
the first FDA-approved venous stent trial,” he said. “This has the
opportunity to help many patients.”

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 United States as well as one in Taiwan.

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.
Dr. Gerard O’Sullivan, interventional radiologist at Galway University
Hospitals in Ireland, will present data from the VIVO-EU study on Nov.
18 at the VEITHsymposium® in New York, NY.

“This is an area of medicine with few treatment options. In fact, there
is no FDA-approved venous stent to treat this painful condition,” said
Mark Breedlove, vice president and global leader of Cook Medical’s
Peripheral Intervention clinical division. “It is our mission to become
a valued partner in the treatment of symptomatic iliofemoral venous
obstruction.”

Read more
on the VIVO Clinical Study.

Drs. Anthony Comerota and Lawrence “Rusty” Hofmann are paid
consultants of Cook Medical.

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop
technologies that eliminate the need for open surgery. Today we are
combining medical devices, biologic materials and cellular therapies to
help the world’s healthcare systems deliver better outcomes more
efficiently. We have always remained family owned so that we have the
freedom to focus on what we care about: patients, our employees and our
communities. Find out more at www.cookmedical.com, and
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