Berlin Heart EXCOR and ACTION post-approval surveillance study report
F Zafar, J Conway, MS Bleiweis, M Al-Aklabi… - The Journal of Heart and …, 2021 - Elsevier
BACKGROUND The Berlin Heart EXCOR Pediatric (EXCOR) ventricular assist device (VAD)
was introduced in North America nearly 2 decades ago. The EXCOR was approved under
Humanitarian Device Exemption status in 2011 and received post-market approval (PMA) in
2017 from Food and Drug Administration. Since the initial approval, the field of pediatric
mechanical circulatory support has changed, specifically with regard to available devices,
anticoagulation strategies, and the types of patients supported. This report summarizes the …
was introduced in North America nearly 2 decades ago. The EXCOR was approved under
Humanitarian Device Exemption status in 2011 and received post-market approval (PMA) in
2017 from Food and Drug Administration. Since the initial approval, the field of pediatric
mechanical circulatory support has changed, specifically with regard to available devices,
anticoagulation strategies, and the types of patients supported. This report summarizes the …
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