TherOx to Begin IDE Trial for Supersaturated Oxygen Therapy System

Irvine, Calif.-based TherOx Inc. has earned investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for a confirmatory safety study of a second generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction AMI. This 100-patient study is being conducted to support a premarket approval submission to the FDA.

“In multiple peer-reviewed studies, we have found the infarct size reduction achieved by SSO2 Therapy was clinically significant compared to PCI [percutaneous coronary intervention],” said Simon Dixon, MBChB, chair of cardiovascular medicine at Beaumont Hospital Royal Oak and an investigator for this study. “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 the first treatment option beyond PCI to salvage heart muscle in heart attack patients. According to the American Heart Association, every year nearly one million people in the United States have heart attacks. Although PCI is the standard of care in treating AMI, for many patients it doesn’t do enough to reduce infarct size and 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. SSO2 therapy is intended to salvage the jeopardized myocardium and thus reduce infarct size.

“This IDE study is an important milestone toward bringing SSO2 Therapy to the U.S. market,” said Kevin T. Larkin, president and CEO of TherOx. “Initiating this new study moves us another step closer to our goal of providing substantially better options for treating heart attack patients.”