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Merit Medical announces FDA approval of WRAPSODY Cell-Impermeable Endoprosthesis
The Fly

Merit Medical announces FDA approval of WRAPSODY Cell-Impermeable Endoprosthesis

Merit Medical (MMSI) Systems announced that the WRAPSODY Cell-Impermeable Endoprosthesis has received premarket approval from the US Food and Drug Administration. With this approval, Merit can begin commercialization of the device in the USA in 2025. WRAPSODY is designed to extend long-term vessel patency in dialysis patients. Many patients undergoing dialysis rely on a vascular access site created in the arm called an arteriovenous fistula or an AV graft. The maintenance of adequate blood flow through these sites is crucial for patient survival. Over time, life-threatening access site complications can arise, including stenosis and thrombosis.

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