Key result
TAVR approval lags in the US versus Europe due to rigorous clinical testing requirements.
Why the study?
The penetration rate of TAVR devices is significantly delayed in the USA compared with Europe due to rigorous regulatory requirements, despite the USA's major role in TAVR development and evaluation.
This review highlights the historical and regulatory context of TAVR development in the USA, emphasizing its contribution to the rigorous scientific evaluation of the technology.
Stricter US regulations delay TAVR access versus Europe; leaves open optimal balance between safety evidence and timely innovation.
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. La pénétration des dispositifs médicaux et des valves aortiques percutanées en particulier est retardée aux États-Unis comparé à l’Europe. Cela est essentiellement lié au processus réglementaires de régulation aux États-Unis qui requiert une évaluation clinique très rigoureuse avant approbation des dispositifs. Les États-Unis ont joué un rôle majeur dans le développement de cette technologie et l’évaluation scientifique a permis aux cliniciens à travers le monde d’obtenir une évaluation concise « basée sur les preuves » de la performance des valves percutanées en termes de sécurité et d’efficacité. Nous allons dans cette mise au point, décrire le développement des valves aortiques percutanées aux USA, et le rôle majeur joué par les États-Unis dans cet extraordinaire aventure « process ».
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Dvir et al. (2012) conducted a review in Aortic valve disease requiring transcatheter aortic valve replacement. Transcatheter aortic valve replacement (TAVR) was evaluated. The penetration and approval of transcatheter aortic valve replacement devices in the USA has been delayed compared to Europe due to rigorous clinical testing requirements by regulatory agencies.
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