VentrAssist gets TGA approval
Monday, 06 August, 2007
Sydney medical device manufacturer Ventracor has received approval from the Therapeutic Goods Administration (TGA) to sell its left ventricular assist device (LVAD) in Australia.
VentrAssist is an implantable blood pump that connects to the left ventricle to assist the diseased heart's pumping function.
It was designed mainly as an alternative to heart transplants.
It has been available previously for advanced heart failure patients participating in clinical trials.
In June, Ventracor achieved a $28.4 million capital raising to increase the number of clinical trial sites in the US for its Bridge to Transplant (BTT) and Destination Therapy (DT) trials.
The BTT trial involves up to 140 patients at heart transplant hospitals in America, with the aiming of evaluating the safety and efficacy of the device in patients whose heart deteriorates before a donor heart becomes available.
The DT protocol is a prospective, randomised, controlled trial. Both trials are being run concurrently.
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