US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) has been granted for a confirmatory safety study of a second generation system which delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an AMI, according to TherOx. This study—which will recruit 100 patients—is taking place to support a pre-market approval (PMA) application to the FDA.
Simon Dixon, chair of cardiovascular medicine at Beaumont Hospital Royal Oak and an investigator for this study, notes, “In multiple peer-reviewed studies, we have found the infarct size reduction achieved by SSO2 Therapy was clinically significant compared to PCI. I am excited about the potential that SSO2 therapy shows in improving outcomes for patients experiencing large anterior infarcts and treated within six hours of onset.”
SSO2 Therapy is intended to provide interventional cardiologists with a first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients. For many patients PCI reduce infarct size enough to achieve maximum clinical benefit. SSO2 Therapy, adjunctive to PCI, is a solution of highly oxygenated saline mixed with the patient’s blood delivered through a catheter to the targeted ischemic area of the heart, intended to salvage the myocardium and thus reduce infarct size.