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Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
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