FDA okays Thoratec's implantable VAD (ventricular assist device) trial:
This article was originally published in Clinica
Executive Summary
Thoratec has gained a conditional approval from the US FDA to begin a clinical trial of an implantable version of its FDA-approved paracorporeal ventricular assist device (VAD). The product, which has an outer housing made of titanium alloy, weighs under a pound (less than 0.5kg). It will be assessed in 30 patients at 10 heart centres, says the Pleasanton, California company. Thoratec is one of three companies in recent weeks to gain US approval to start clinical trials of an implantable VAD or heart replacement device (see Clinica No 946, p 19).
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