February 22, 2016 — TherOx Inc. announced the first patient has been enrolled in an Investigational Device Exemption (IDE) confirmatory study of its second-generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an acute myocardial infarction (AMI). This study is being conducted to support a premarket approval submission to the U.S. Food and Drug Administration (FDA).
“Many heart attack patients suffer from large anterior infarcts after angioplasty and stenting, which carry a poorer prognosis in terms of mortality and the potential for future heart failure,” said Shukri David, M.D., FACC, physician chair of the Heart & Vascular Center of Excellence at St. John Providence Health System near Detroit, Mich., and an investigator for this study. “This important study of SSO2 therapy may provide physicians with an additional intervention that further improves outcomes for our heart attack patients.”
Called the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study, it will enroll 100 subjects at up to 15 investigational centers in the United States. The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 therapy in treatment of anterior AMI patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.
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 is intended to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients. 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. The therapy is intended to salvage the jeopardized myocardium and thus reduce infarct size. Multiple peer-reviewed studies have demonstrated the infarct size reduction achieved by SSO2 therapy was clinically significant compared to PCI alone.
For more information: www.therox.com