Medical technology company BD (Becton, Dickinson and Company) (NYSE:BDX) reported on Thursday the receipt of the US Food and Drug Administration's premarket approval for the Venovo venous stent for the treatment of iliofemoral venous occlusive disease.
Iliofemoral venous occlusive disease occurs when there is impaired blood flow in the iliofemoral vein caused by acute or chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral vein compression including May-Thurner Syndrome or a combination of these diseases.
The US FDA's premarket approval for the company's Venovo venous stent is reportedly the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin.
According to the company, 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. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.
Based on the one-year results from the prospective, multicentre single-arm Venovo VERNACULAR trial involving 170 subjects, the clinical findings 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, said the company.
In addition, the Venovo venous stent is commercially available in the US, Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan, concluded the company.
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