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Medical Devices / Submissions and Approvals

Boston Scientific Gains FDA Nod for Venous Stent

May 7, 2019
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Boston Scientific has earned the FDA’s premarket approval for the Vici Venous Stent system, a device used for treating iliofemoral venous obstructive disease.

Venous obstructive disease occurs when blood flow in the pelvic veins is compressed or blocked by a blood clot.

The stent’s approval was based on data from a multi-center trial with 170 patients. The VIRTUS study met its primary safety and effectiveness endpoints.

The stent resists the compression encountered frequently in the iliofemoral venous system through its strong and crush resistant design and restores blood flow by creating a cylindrical vessel.

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