BD’s venous stent gets US FDA approvalMay 8, 2019
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.