|Trade Name||THORETEC HEARTMATE XVE LVAS|
|Classification Name||ventricular (assisst) bypass|
|Generic Name||ventricular (assisst) bypass|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an expanded indication for use for the thoratec heartmate xve lvas. This device system is indicated for use as a bridge to cardiac transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. It is now also indicated for use in patients with new york heart association class iv end stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, and who have a life expectancy of less than two years, and who are not eligible for cardiac transplantation. The device system is approved for use both inside and outside the hospital.