IP177. Drug-Coated Balloon Catheters: What Is Being Reported in the MAUDE Database?

The Manufacturer and User Facility Device Experience (MAUDE) Database was established by the United States Food and Drug Administration (FDA) to allow for voluntarily reporting of adverse outcomes with medical devices. There are two commercially available drug-coated balloons: IN.PACT Admiral (I-DCB; Medtronic, Inc; release date 1/5/2015) and Lutonix (L-DCB; C.R. Bard, Inc; release date 10/9/2014). We sought to examine MAUDE reporting of these two systems.

http://www.jvascsurg.org/article/S0741-5214(17)30629-8/fulltext?rss=yes

Source: Journal of Vascular Surgery - May 17, 2017 Category: Surgery Authors: Michael F. Amendola, Ifechukwude Ikem, Gi-Ann Acosta Tags: IP: Interactive Poster Session Source Type: research

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