MicroMed to begin pivotal DeBakey VAD (ventricular assist device) trial in US:
This article was originally published in Clinica
The US FDA has given MicroMed the go-ahead to begin a pivotal, multicentre clinical study of its DeBakey miniaturised ventricular assist device (VAD). The phase III trial is expected to take place at around 20 sites and will involve around 178 treated and control subjects, says the Houston, Texas, company. Researchers will test the VAD's effectiveness as a bridge-to-heart transplant.
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