PMA Accepted for TherOx Myocardial Infarction Device

FDA has accepted for review a TherOx Inc. PMA for its Supersaturated Oxygen (SSO2) Therapy system, intended for use in reducing infarct size and improving outcomes in anterior acute myocardial infarction (AMI) patients treated within six hours of symptom onset. While percutaneous coronary intervention is the standard of care in treating AMI, for many patients it doesn’t sufficiently reduce infarct size to achieve maximum clinical benefit, the company says. In SSO2 therapy, a patient’s blood is supersaturated with oxygen and then returned directly to the targeted ischemic area of the heart through a small catheter to salvage heart muscle and reduce infarct size, it says. The submission includes data from the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study, a confirmatory study that enrolled 100 patients at 15 investigational centers in the U.S.