Cook Medical has enrolled the first ten patients in its VIVO clinical research study, designed to evaluate the safety and effectiveness of treating symptomatic iliofemoral venous outflow obstruction with the Zilver Vena venous self-expanding stent.
The first patients enrolled in the study are undergoing treatment at six healthcare facilities in the East Coast and Midwest regions.
Piedmont Heart Institute chief of vascular and endovascular services Dr Charles B Ross was the first physician to enroll a patient in the study.
Dr Ross said he is 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," Dr Ross added.
According to the company, the Zilver Vena venous self-expanding stent is an investigational device and is not approved for sale in the US.
Cook Peripheral Intervention clinical division vice president and global leader Mark Breedlove said the company sees this as an important step in the battle against iliofemoral venous outflow obstruction.
"By conducting the VIVO clinical research study, we hope to advance our understanding of venous disease while providing new treatment options for patients," Breedlove added.