New heart pump to begin US trials:
This article was originally published in Clinica
Executive Summary
Cardiac Assist Technologies has begun an FDA-approved clinical trial of its heart pump in the US. The five-patient feasibility trial under an Investigational Device Exemption, will be carried out to evaluate the safety of the AB-180 CSS ventricular assist device and to fine-tune the clinical protocol in preparation for multi-centre clinical trials of the device. The Pittsburgh-based company has also begun clinical studies of the device in the UK, Switzerland and South Africa.