FDA-Cleared Access Program Bodes Well For HeartMate Trial, Thoratec Says
This article was originally published in The Gray Sheet
Executive Summary
FDA's decision allowing Thoratec to make the HeartMate VE battery-powered left ventricular assist system available to patients outside its IDE trial indicates preliminary survival data are "very encouraging," the company says.
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HeartMate II
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
HeartMate II
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
Arrow's LionHeart
Phase I clinical trials evaluating fully implantable left-ventricular assist system (LVAS) for alternative-to-transplant indication expected to begin by March, firm reports following receipt of investigational device exemption approval. Five-site trial to include up to seven congestive heart failure patients who are not candidates for heart transplant and are refractory to drug therapy. Phase II studies are expected to begin by the end of the firm's fiscal year 2001 (ending Aug. 31, 2001). The firm expects to complete by September a 30 to 40-patient European study to support a CE mark