The development of transcatheter aortic valve replacement in the USA. [Review]

MedStar author(s):
Citation: Archives of cardiovascular diseases. 105(3):160-4, 2012 Mar.PMID: 22520799Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Aortic Valve/su [Surgery] | *Cardiac Catheterization/td [Trends] | *Heart Valve Prosthesis Implantation/td [Trends] | Heart Valve Prosthesis Implantation/mt [Methods] | Humans | United StatesISSN:
  • 1875-2128
Name of journal: Archives of cardiovascular diseasesAbstract: The penetration rate of devices in general, and in transcatheter aortic valve replacement (TAVR) specifically, is significantly delayed in the United States of America (USA) compared with in Europe. This is mostly due to the mission statement of the regulatory agencies in the USA, which requires very rigorous clinical testing of a device prior to its approval. The USA had a major role in the development and evaluation of this technology and USA research has enabled clinicians inside and outside of the USA to conduct a concise scientifically based assessment of the performance of TAVR devices in terms of safety and efficacy. In the following review, we provide data on the development of TAVR in the USA, revealing the critical role the USA has played in this extraordinary process. Copyright 2012 Elsevier Masson SAS. All rights reserved.All authors: Barbash IM, Ben-Dor I, Dvir D, Okubagzi P, Pichard AD, Satler LF, Waksman RDigital Object Identifier: Date added to catalog: 2013-09-17
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Journal Article MedStar Authors Catalog Article Available 22520799

The penetration rate of devices in general, and in transcatheter aortic valve replacement (TAVR) specifically, is significantly delayed in the United States of America (USA) compared with in Europe. This is mostly due to the mission statement of the regulatory agencies in the USA, which requires very rigorous clinical testing of a device prior to its approval. The USA had a major role in the development and evaluation of this technology and USA research has enabled clinicians inside and outside of the USA to conduct a concise scientifically based assessment of the performance of TAVR devices in terms of safety and efficacy. In the following review, we provide data on the development of TAVR in the USA, revealing the critical role the USA has played in this extraordinary process. Copyright 2012 Elsevier Masson SAS. All rights reserved.

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