Endologix receives US FDA approval of PMA supplement for AFX2 system

Endologix recently announced that it has received US Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system. According to a company press release, Endologix received approval to include an updated warning and the most contemporary clinical information in the labelling for the AFX2 system. Clinical data added […]

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Endologix submits premarket approval application to FDA for Detour system

Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration (FDA). The Detour system, which earned FDA Breakthrough Device Designation, is a unique therapy that allows the creation of a fully percutaneous femoropopliteal bypass that is routed through the femoral vein. […]

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