FDA panel sets review date for Thoratec's LVAS (left ventricular assist system):
This article was originally published in Clinica
Executive Summary
An advisory panel to the US FDA is scheduled to review Thoratec's application to expand the intended use of its HeartMate VE LVAS (left ventricular assist system) on March 4. The company's premarket approval supplement, which is based on the results of Thoratec's REMATCH trial (see Clinica, No 985, p 17), is seeking clearance to use the device for long-term support in end-stage heart failure patients who are not eligible for heart transplantation. The device is currently approved for use as a bridge to heart transplant, says the Pleasanton, California firm.