BD’s venous stent gets US FDA approval

May 8, 2019 0 By FM

The US FDA has granted premarket approval for the Venovo venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, BD announced.

The Venovo venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The Venovo venous stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic  post-thrombotic and non-thrombotic iliofemoral lesions.

The broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.

One-year results from the prospective, multicentre single-arm VERNACULAR trial involving 170 subjects demonstrated the safety and effectiveness of the Venovo venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction.

The clinical findings showed a weighted primary patency rate of 88.3 percent, with a 96.9 percent patency rate in non-thrombotic lesions and an 81.3 percent patency rate in post-thrombotic lesions at 12 months, exceeding the performance goal of 74 percent.

In addition, patients treated with the Venovo venous stent reported a statistically significant reduction in pain symptoms, according to the BD statement.