Thoratec seeks expanded approval for heart assist pump
This article was originally published in Clinica
Executive Summary
Thoratec Laboratories has asked the US FDA to expand approval of its heart-assist pump to include support for heart-surgery patients. The VAD system is currently the only heart-pump approved in the US for use in the left, right or both sides of the heart in patients waiting for transplants. Most devices are approved only for left-ventricular support, by far the biggest market of the three.