TherOx, Inc., is a privately held medical device company with a focus on improving treatment of Acute Myocardial Infarction. Today they announced that results of its IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study successfully met its primary endpoint. The purpose of this study was to confirm the safety and effectiveness of Supersaturated Oxygen (SSO2) Therapy in treatment of anterior AMI patients who have undergone successful percutaneous coronary intervention with stenting within six hours of experiencing AMI symptoms. These results are included in the Premarket Approval (PMA) application for the SSO2 Therapy system that has been accepted for filing by the U.S. Food and Drug Administration. The study results were presented at the 29th Transcatheter Cardiovascular Therapeutics, the annual scientific symposium of the Cardiovascular Research Foundation.
Gregg W. Stone, MD, principal investigator of the IC-HOT study and professor of medicine at Columbia University Medical Center, said, “Supersaturated oxygen is the only therapy shown in a pivotal randomized trial to reduce the important endpoint of infarct size in patients with large myocardial infarction.” Dr. Stone highlighted, “The IC-HOT study, using a simpler delivery method than previously tested, demonstrated that use of supersaturated oxygen is safe after successful primary stenting in high-risk patients with anterior myocardial infarction.”
IC-HOT is a confirmatory study of the second-generation TherOx system that delivers SSO2 Therapy for reduction of infarct size after an AMI. The study enrolled 100 patients at 15 investigational centers in the U.S. IC-HOT results build on the successful outcome of the AMIHOT II controlled, randomized pivotal trial that studied the first-generation SSO2 Therapy system, and combined these study results provide the FDA with the basis for PMA approval.
The president and chief executive officer of TherOx, Kevin T. Larkin adds, “The IC-HOT study clearly met its endpoint with good margin, and with successful study completion and subsequent notice of the FDA’s acceptance for filing, TherOx’s PMA is now under final review.” He concluded, “We continue to move closer to enabling physicians to provide this important new therapy to their patients who experience typically debilitating large anterior AMIs.”
SSO2 Therapy is intended to provide interventional cardiologists with the first treatment option beyond PCI to salvage heart muscle in heart attack patients. Although percutaneous coronary intervention (PCI) is the standard of care in treating AMI, for many patients it doesn’t sufficiently reduce infarct size to achieve maximum clinical benefit. In SSO2 Therapy, the patient’s blood is supersaturated with oxygen and then returned directly to the targeted ischemic area of the heart through a small catheter. Adjunctive to PCI, SSO2 Therapy is intended to salvage heart muscle and reduce infarct size.