Medical device firm TherOx has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the study of next generation supersaturated oxygen (SSO2) therapy for acute myocardial infarction (AMI).
The approval has been granted for a confirmatory safety study of a second generation system that delivers SSO2 to reduce infarct size after an AMI.
SSO2 Therapy will offer interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients.
It was developed to reduce infarct size by enhancing oxygen delivery to the heart muscle immediately after the coronary artery has been opened by PCI.
Beaumont Hospital Royal Oak cardiovascular medicine chair and study investigator Dr Simon Dixon said: "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."
The firm will use the study data to support a premarket approval submission to the FDA.
According to the firm, SSO2 therapy 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.
The first generation system to deliver SSO2 therapy obtained CE mark approval, and reached the safety and effectiveness endpoints in the AMIHOT II trial.
TherOx president and CEO Kevin Larkin said: "Initiating this new study moves us another step closer to our goal of providing substantially better options for treating heart attack patients."