Comparison of the investigational device exemption and post‐approval trials of the Melody transcatheter pulmonary valve-Reference-Cited by-同舟云学术

Comparison of the investigational device exemption and post‐approval trials of the Melody transcatheter pulmonary valve

Published:2021-03-29 Issue:2 Volume:98 Page:
ISSN:1522-1946
Container-title:Catheterization and Cardiovascular Interventions
language:en
Short-container-title:Catheter Cardiovasc Interv

Author:

Kreutzer Jacqueline¹,Armstrong Aimee K.²^ORCID,Rome Jonathan J.³,Zellers Thomas M.⁴,Balzer David T.⁵,Zampi Jeffrey D.⁶^ORCID,Cabalka Allison K.⁷,Javois Alexander J.⁸,Turner Daniel R.⁹,Gray Robert G.¹⁰^ORCID,Moore John W.¹¹^ORCID,Weng Shicheng¹²,Jones Thomas K.¹³^ORCID,Khan Danyal M.¹⁴,Vincent Julie A.¹⁵,Hellenbrand William E.¹⁶,Cheatham John P.²,Bergersen Lisa J.¹⁷,McElhinney Doff B.¹⁸

Affiliation:

1. Division of Cardiology, Department of Pediatrics University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania USA

2. The Heart Center Nationwide Children's Hospital Columbus Ohio USA

3. Division of Cardiology Children's Hospital of Philadelphia Philadelphia Pennsylvania USA

4. Division of Cardiology, Department of Pediatrics University of Texas Southwestern and the Heart Center at Children's Health Dallas Texas USA

5. Division of Pediatric Cardiology Washington University School of Medicine/Saint Louis Children's Hospital St. Louis Missouri USA

6. Division of Pediatric Cardiology University of Michigan Medical School Ann Arbor Michigan USA

7. Division of Cardiology Mayo Clinic Rochester Minnesota USA

8. Advocate Children's Hospital, Section of Pediatric Cardiology, Advocate Children's Hospital University of Illinois Hospital Chicago Illinois USA

9. Division of Cardiology, Carman and Ann Adams Department of Pediatrics Children's Hospital of Michigan Detroit Michigan USA

10. Department of Pediatrics, Division of Pediatric Cardiology University of Utah Salt Lake City Utah USA

11. Department of Pediatric Cardiology Rady Children's Hospital, UC San Diego San Diego California USA

12. Department of Biostatistics Medtronic Framingham Massachusetts USA

13. Department of Cardiology Seattle Children's Hospital Seattle Washington USA

14. The Heart Program Nicklaus Children's Hospital Miami Florida USA

15. Division of Pediatric Cardiology Columbia University Medical Center New York New York USA

16. Department of Pediatrics (Cardiology) Yale University School of Medicine New Haven Connecticut USA

17. Department of Cardiology Boston Children's Hospital Boston Massachusetts USA

18. Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital Stanford University School of Medicine Palo Alto California USA

Funder

Medtronic

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/ccd.29657

Reference36 articles.

1. Assessing the cost burden of United States FDA‐mandated post‐approval studies for medical devices;Wimmer NJ;J Health Care Finance,2017

2. Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval

3. Postmarketing Trials and Pediatric Device Approvals

4. High-Risk Medical Devices, Children and the FDA: Regulatory Challenges Facing Pediatric Mechanical Circulatory Support Devices

5. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011

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1. Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry;European Heart Journal;2023-10-24

2. Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves;International Journal of Cardiology;2023-01

3. Transcatheter Approaches to Pulmonary Valve Replacement in Congenital Heart Disease: Revolutionizing the Management of RVOT Dysfunction?;Seminars in Thoracic and Cardiovascular Surgery;2022-03

4. Ongoing Learning With Transcatheter Pulmonary Valve Replacement;JACC: Cardiovascular Interventions;2022-01

5. Transcatheter pulmonic valve implantation in adult patients with prior congenital heart surgery;Annals of Cardiothoracic Surgery;2021-09