Literature DB >> 15226222

Post-market approval surveillance: a call for a more integrated and comprehensive approach.

Roxana Mehran1, Martin B Leon, David A Feigal, David Jefferys, Michael Simons, Nicholas Chronos, Thomas J Fogarty, Richard E Kuntz, Donald S Baim, Aaron V Kaplan.   

Abstract

Mesh：

Year:  2004        PMID： 15226222     DOI： 10.1161/01.CIR.0000134694.78653.B6

Source DB:  PubMed          Journal:  Circulation        ISSN： 0009-7322            Impact factor:   29.690


× No keyword cloud information.
  10 in total

1.  Reporting of adverse events in surgical trials: critical appraisal of current practice.

Authors:  Rachel Rosenthal; Henry Hoffmann; Kerry Dwan; Pierre-Alain Clavien; Heiner C Bucher
Journal:  World J Surg       Date:  2015-01       Impact factor: 3.352

2.  Registry-Based Prospective, Active Surveillance of Medical-Device Safety.

Authors:  Frederic S Resnic; Arjun Majithia; Danica Marinac-Dabic; Susan Robbins; Henry Ssemaganda; Kathleen Hewitt; Angelo Ponirakis; Nilsa Loyo-Berrios; Issam Moussa; Joseph Drozda; Sharon-Lise Normand; Michael E Matheny
Journal:  N Engl J Med       Date:  2017-01-25       Impact factor: 91.245

3.  Active Surveillance of the Implantable Cardioverter-Defibrillator Registry for Defibrillator Lead Failures.

Authors:  Frederic S Resnic; Arjun Majithia; Sanket S Dhruva; Henry Ssemaganda; Susan Robbins; Danica Marinac-Dabic; Kathleen Hewitt; Lucila Ohno-Machado; Matthew R Reynolds; Michael E Matheny
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2020-04-14

4.  The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance.

Authors:  Amit Kumar; Michael E Matheny; Kalon K L Ho; Robert W Yeh; Thomas C Piemonte; Howard Waldman; Pinak B Shah; Richard Cope; Sharon-Lise T Normand; Sharon Donnelly; Susan Robbins; Frederic S Resnic
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2014-12-09

Review 5.  Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

Authors:  Julie Polisena; Alan J Forster; Karen Cimon; Danielle Rabb
Journal:  Syst Rev       Date:  2013-10-10

6.  Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice.

Authors:  Sanket S Dhruva; Shumin Zhang; Jiajing Chen; Peter A Noseworthy; Amit A Doshi; Kolade M Agboola; Jeph Herrin; Guoqian Jiang; Yue Yu; Guy Cafri; Kimberly Collison Farr; Keondae R Ervin; Joseph S Ross; Paul M Coplan; Joseph P Drozda
Journal:  JAMA Netw Open       Date:  2022-08-01

Review 7.  Medical device assessment: scientific evidence examined by the French national agency for health - a descriptive study.

Authors:  Laure Huot; Evelyne Decullier; Karen Maes-Beny; Francois R Chapuis
Journal:  BMC Public Health       Date:  2012-08-01       Impact factor: 3.295

8.  A proposed framework to improve the safety of medical devices in a Canadian hospital context.

Authors:  Julie Polisena; Jeffrey Jutai; Rana Chreyh
Journal:  Med Devices (Auckl)       Date:  2014-05-16

9.  A Primer to the Structure, Content and Linkage of the FDA's Manufacturer and User Facility Device Experience (MAUDE) Files.

Authors:  Lisa Garnsey Ensign; K Bretonnel Cohen
Journal:  EGEMS (Wash DC)       Date:  2017-06-14

10.  Impact of early surveillance on safety signal identification in the CathPCI DELTA study.

Authors:  Arjun Majithia; Michael E Matheny; Sourbha S Dani; Jessica K Paulus; Danica Marinac-Dabic; Susan Robbins; Henry Ssemaganda; Kathleen Hewitt; Angelo Ponirakis; Nilsa Loyo-Berrios; Issam Moussa; Joseph Drozda; Sharon-Lise Normand; Frederic S Resnic
Journal:  BMJ Surg Interv Health Technol       Date:  2020-11-11
  10 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.