Vivo 12-month study
Vivo evaluated the Cook Medical Zilver vena venous stent for treating patients with symptomatic iliofemoral venous outflow obstruction.
The primary endpoints were 30-day freedom from major adverse events, procedural bleeding requiring transfusion, procedure-related or device-related death, clinically-driven reintervention, clinical migration, new symptomatic pulmonary embolism or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel. The primary effectiveness endpoint was 12-month rate of primary quantitative patency.
Among 243 enrolled patients, 30-day freedom from MAE rate was 96.7%, exceeding the goal set at 87%. The 12-month primary quantitative patency rate was 89.9%, exceeding the goal of 76%.
Results supported the safety and effectiveness of the Zilver stent for treating symptomatic iliofemoral venous outflow obstruction.