TherOx Enrolls First Patient in Study of Next-Generation Supersaturated Oxygen Therapy for AMI

IRVINE, Calif.,  TherOx, Inc., a privately held medical device company focused on improved treatment of Acute Myocardial Infarction (AMI), announced that 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 AMI. This study is being conducted to support a PreMarket Approval submission to the 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, MD, FACC, Physician Chair of the Heart & Vascular Center of Excellence at St. John Providence Health System near Detroit, MI, 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 U.S. have heart attacks. Although percutaneous coronary intervention (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. SSO₂ 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.

“This study moves us another step closer to our goal of improving treatment options in the U.S. for physicians to provide to their heart attack patients,” said Kevin T. Larkin, president and chief executive officer of TherOx.

Source: TherOx, Inc.