November 6, 2020
Cook's Zilver Vena Venous Stent Supported by 12-Month VIVO Study Results
November 6, 2020—Results from the VIVO clinical study supporting the safety and effectiveness of the Zilver Vena venous stent (Cook Medical) for the treatment of symptomatic iliofemoral venous outflow obstruction were presented by Anthony Comerota, MD.
The VIVO study enrolled 243 patients with symptomatic obstruction (CEAP [clinical, etiology, anatomy, pathophysiology] clinical classification ≥ 3 or venous clinical severity score [VCSS] ≥ 2) of one iliofemoral venous segment. The primary safety endpoint was 30-day freedom from major adverse events (MAEs). The primary effectiveness endpoint was 12-month rate of primary quantitative patency. The secondary endpoint was the change in VCSS from baseline to 1 and 12 months.
Dr. Comerota presented the findings in a late-breaking clinical trials session at VIVA 2020, the Vascular InterVentional Advances annual meeting held virtually from November 6-8, 2020.
According to the VIVA press release, MAEs in the study were defined as procedural bleeding requiring transfusion; procedure- or device-related death; clinically driven reintervention (reintervention with recurrent symptoms of venous outflow obstruction of the target lesion and a minimum lumen diameter [MLD] ≤ 50% as determined by immediate postprocedure MLD on venography); clinical migration; new symptomatic pulmonary embolism; procedure-related perforation requiring open surgical repair; or flow-limiting dissection of the target vessel. Primary quantitative patency was defined as intervention-free, MLD > 50% of the immediate postprocedure MLD on venography.
Mean age of patients was 53 ± 15 years and 70% were female. The primary indication for stent placement was iliac vein compression by the iliac artery (n = 191; 78.6%). The mean lesion length at baseline was 98.6 ± 69.8 mm. Technical success (ability to deliver and place stent in intended location) was achieved for 97.3% of stents.
The 30-day freedom from MAE rate was 96.7%, exceeding the performance goal of 87% (95% CI, 93.5%-98.6%; P < .0001). The 12-month primary quantitative patency rate was 89.9%, exceeding the performance goal of 76% (95% CI, 85.1%-93.4%; P < .0001). Mean change in VCSS was significant at 1 month (-3.0; 95% CI, -3.5 to -2.6; P < .0001) and maintained through 12 months (-4.2; 95% CI, -4.7 to -3.7; P < .0001), reported Dr. Comerota at VIVA 2020.
On October 15, Cook Medical announced FDA premarket approval of the Zilver Vena venous stent, which the company aims to have commercially available in Q4 2020.