Becton Dickinson's Venovo venous stent gains FDA approval

Becton Dickinson announced Thursday that the FDA awarded premarket approval to the Venovo venous stent, which the company said is the first stent indicated to treat iliofemoral venous occlusive disease. Steve Williamson, worldwide president of peripheral intervention at Becton Dickinson, said "we designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions."

According to the company, the flexible nitinol stent is designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The 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," Becton Dickinson said, adding that "the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths."

Becton Dickinson noted that one-year results from the VERNACULAR trial, which included 170 participants, showed a weighted primary patency rate of 88.3 percent for the Venovo stent, with a 96.9 percent patency rate in non-thrombotic lesions and an 81.3 percent patency rate in post-thrombotic lesions, which exceeded the performance goal of 74 percent. Additionally, patients treated with the stent reported a significant reduction in pain and improvement in quality of life at 12 months from baseline. The Venovo stent was also deployed successfully and showed adequate coverage in all cases, with no fractures seen at 12 months.

Along with the US, the stent is commercially available in Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan.

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