US-based TherOx has secured investigational device exemption (IDE) approval from US Food and Drug Administration (FDA) for a confirmatory safety study of next-generation supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction (AMI).
The company is conducting the 100-patient study to support a premarket approval submission to the FDA.
The SSO2 therapy will offer interventional cardiologists the first treatment option beyond percutaneous coronary intervention (PCI) to save heart muscle in heart attack patients.
It was developed to reduce infarct size by improving oxygen delivery to the heart muscle immediately after the coronary artery has been opened by PCI.
Beaumont Hospital Royal Oak cardiovascular medicine chair 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 company noted the 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 safety and effectiveness endpoints in the AMIHOT II trial.
TherOx president 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."
Every year nearly one million people in the US have heart attacks, according to the American Heart Association.
The standard of care in treating AMI is PCI. For many patients it does not do enough to reduce infarct size and achieve maximum clinical benefit.