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Safety  profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016
ConclusionsMAUDE‐reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.
Source: Journal of Cardiovascular Electrophysiology - November 1, 2017 Category: Cardiology Authors: Mohammad ‐Ali Jazayeri, Venkat Vuddanda, Mohit K. Turagam, Valay Parikh, Madhav Lavu, Donita Atkins, Matthew Earnest, Luigi Di Biase, Andrea Natale, David Wilber, Yeruva Madhu Reddy, Dhanunjaya R. Lakkireddy Tags: ORIGINAL ARTICLE Source Type: research

Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the food and drug administration manufacturer and user facility device experience (MAUDE) database from 2009 ‐ 2016
ConclusionsMAUDE‐reported data show that post‐approval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical post‐market training and monitoring mechanisms.This article is protected by copyright. All rights reserved
Source: Journal of Cardiovascular Electrophysiology - October 8, 2017 Category: Cardiology Authors: Mohammad ‐Ali Jazayeri, Venkat Vuddanda, Mohit K. Turagam, Valay Parikh, Madhav Lavu, Donita Atkins, Matthew Earnest, Luigi Di Biase, Andrea Natale, David Wilber, Yeruva Madhu Reddy, Dhanunjaya Lakkireddy Tags: ORIGINAL ARTICLE Source Type: research