TherOx Inc. announced it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a confirmatory safety study of a second-generation supersaturated oxygen (SSO2) therapy system. The system helps reduce infarct size after an acute myocardial infarction (AMI). This 100-patient study is being conducted to support a pre-market approval submission to the FDA.
