510(k) for ESTECH's perfusion cannula:
This article was originally published in Clinica
Executive Summary
ESTECH has received marketing clearance from the US FDA for its remote access perfusion cannula. The device is designed to stop the heart and provide arterial blood flow, allowing cardiac surgery to be performed in a less invasive way through small incisions between the ribs. The multi-function ESTECH cannula delivers blood flow directly to the central aorta in its natural direction unlike other devices which provide blood flow in the opposite direction. Reverse blood flow has been implicated in the occurrences of aortic tears, said the Danville, California-based company.
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