FDA News

Flexible stent receives FDA approval for iliofemoral venous occlusive disease

Michael D. Dake
Michael D. Dake

BD announced that a venous stent for the treatment of patients with iliofemoral venous occlusive disease has been granted premarket approval from the FDA.

This flexible nitinol stent (Venovo, BD) is designed to reopen blocked femoral and iliac veins. The stent also has several features that are required for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions, including compression resistance and radial strength, according to a press release from the company.

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” Michael D. Dake, MD, senior vice president of health sciences and professor of medical imaging, surgery and medicine at the University of Arizona, said in the press release. “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.”

Benefits of this stent were shown in the results of the VENACULAR trial. As Cardiology Today’s Intervention previously reported, the stent was associated with high rates of primary patency and low rates of target lesion revascularization.

“The FDA premarket approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an underrecognized condition,” Steve Williamson, worldwide president of peripheral intervention for BD, said in the press release.

Disclosures: The VERNACULAR study was funded by BD. Dake reports he received honoraria from Bard Peripheral Vascular and Cook Medical, consulted for Cook Medical, Novate Medical and W.L. Gore and Associates, and received research funding from Essential Medical, Novate Medical, Shockwave Medical and W.L. Gore and Associates. Williamson is an employee of BD.

Michael D. Dake
Michael D. Dake

BD announced that a venous stent for the treatment of patients with iliofemoral venous occlusive disease has been granted premarket approval from the FDA.

This flexible nitinol stent (Venovo, BD) is designed to reopen blocked femoral and iliac veins. The stent also has several features that are required for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions, including compression resistance and radial strength, according to a press release from the company.

“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” Michael D. Dake, MD, senior vice president of health sciences and professor of medical imaging, surgery and medicine at the University of Arizona, said in the press release. “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.”

Benefits of this stent were shown in the results of the VENACULAR trial. As Cardiology Today’s Intervention previously reported, the stent was associated with high rates of primary patency and low rates of target lesion revascularization.

“The FDA premarket approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an underrecognized condition,” Steve Williamson, worldwide president of peripheral intervention for BD, said in the press release.

Disclosures: The VERNACULAR study was funded by BD. Dake reports he received honoraria from Bard Peripheral Vascular and Cook Medical, consulted for Cook Medical, Novate Medical and W.L. Gore and Associates, and received research funding from Essential Medical, Novate Medical, Shockwave Medical and W.L. Gore and Associates. Williamson is an employee of BD.