HeartMate II
This article was originally published in The Gray Sheet
Executive Summary
Thoratec will apply for an IDE by year-end to support an alternative-to-transplant indication for its rotary flow pump LVAS. The HeartMate II left ventricular assist system, undergoing European trials, is smaller than the HeartMate VE battery-powered device, currently being studied under an IDE (1"The Gray Sheet" Aug. 20, 2001, p. 8). Thoratec is developing a percutaneous electric lead and transcutaneous energy transmission system for the HeartMate II, components that would allow the device to be fully implantable