BLOOMINGTON, Ind.– 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 for the latest news, follow us on Twitter, Facebook and LinkedIn.