Flexible Stent Treats Iliofemoral Venous Occlusive Disease

The flexible nitinol stent maintains a balance of radial strength, compression resistance, and flexibility specifically designed to meet the demands of veins, as opposed to arteries. For example, the ends are flared to enhance vein-wall apposition, and broad stent sizing allows clinicians to treat large diameter veins (10-20 mm) and long lesion lengths (from 40 mm to 160 mm). Six radiopaque tantalum markers aid in positioning.

A prospective, multicenter, single-arm trial involving 170 patients showed a weighted primary patency rate of 88.3%, with a 96.9% patency rate in non-thrombotic lesions and an 81.3% patency rate in post-thrombotic lesions at 12 months, exceeding the performance goal of 74%. In addition, patients treated with the Venovo reported a significant reduction in pain symptoms and improvement in quality of life at 12 months from baseline. The Venovo venous stent was also deployed successfully to the target lesion and showed adequate coverage in all cases, and there were no fractures seen at 12 months.

“The Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an under recognized condition,” said Steve Williamson, worldwide president of peripheral intervention at BD. "We designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions. Clinicians will now have access to the broadest range of stent sizes in the United States for these difficult-to-treat lesions.”

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” said Michael Dake, MD, of the University of Arizona, the principal investigator for the Venovo U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) trial. “Most importantly, it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”

IVOD occurs when there is impaired blood flow in the iliofemoral vein caused by acute or chronic deep-vein thrombosi (DVT), post-thrombotic syndrome, iliofemoral vein compression (including May-Thurner Syndrome), or a combination of these diseases. Symptoms include swelling of the legs, pain when standing, skin discoloration and ulcers.