Bridge crossed by HeartWare
Tuesday, 23 September, 2008
The US FDA has approved the left ventricular assist system [LVAS] developed by HeartWare [ASX: HTW] for an Investigational Device Exemption (IDE).
The company is now clear to conduct clinical trials of the device, which are to be held at the Washington Hospital Centre, with one patient already enrolled.
The trial is a bridge-to-transplant trial in patients with end-stage heart failure.
HeartWare is in the process of finalising contractual arrangements at a number of additional centres. Seven centres so far have been trained in the use of the product.
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