Cook Medical tells us that the first ten patients have been enrolled in its VIVO clinical research study, a trial that was initiated last April and will form a key part of the device’s quest for U.S. FDA approval.
Background
More than 50 per cent of patients who develop nonfatal Venous Thromboembolism (VTE) will reportedly go on to develop post-thrombotic syndrome, chronic scarring of the thrombosed veins, resulting in venous outflow obstruction and venous hypertension.
Based on Cook’s Zilver technology, Zilver® Vena™ is designed to address many of the challenges of stenting diseased veins, which are very different from diseased arteries, veins requiring a stent with strong radial force, good flexibility and large diameters. Zilver Vena was first launched in 2011 internationally, but stent remains currently an investigational device in the United States and as such not available for sale.
Kicked off officially last April as we reported here, the VIVO study is designed to evaluate the safety and effectiveness of treating symptomatic iliofemoral venous outflow obstruction with the Zilver® Vena™ Stent. The trial’s first patients are undergoing treatment at six healthcare facilities in the East Coast and Midwest regions.
Investigator comments
Dr. Charles B. Ross, chief of vascular and endovascular services at Piedmont Heart Institute was the first physician to enroll a patient in the study and stated; “I am overjoyed to be part of a trial specifically designed to address iliofemoral venous outflow obstruction with a stent designed for this purpose,” said Dr. Ross. “With the Zilver Vena stent and VIVO trial, we enter a new and exciting era. I feel privileged to participate.”
Company comments
“Cook sees this as an important step in the battle against iliofemoral venous outflow obstruction,” explained Mark Breedlove, vice president and global leader of Cook’s Peripheral Intervention clinical division. “By conducting the VIVO clinical research study, we hope to advance our understanding of venous disease while providing new treatment options for patients.”
The Zilver Vena Venous Self-Expanding Stent is an investigational device that is not approved for sale in the United States.
Source: Cook Medical, Business Wire
published: March 3, 2014 in: Clinical Studies/Trials, Cook, Vascular