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FDA greenlights light-activated device for use in vascular disease trial

August 3, 2023

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Adrug-coated balloon that helps restore blood vessels via light activation has been approved for use in US clinical trials, following an investigational device exemption (IDE) by the US Food and Drug Administration (FDA).

Alucent Biomedical’s light-activated, drug-coated balloon catheter technology creates a natural, stent-like scaffold that harnesses structures and processes already present in the vessel wall to treat peripheral artery disease and help haemodialysis patients with arteriovenous fistula maturation.

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