The first patient has been enrolled in an investigational device exemption confirmatory study of the second-generation supersaturated oxygen system (SSO2, TherOx) for the improved treatment of acute myocardial infarction (AMI).
The study will investigate the ability of SSO2 therapy to reduce infarct size after AMI, and is being conducted to support a premarket approval submission to the US Food and Drug Administration.
“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,” saysShukri David, physician chair of the Heart & Vascular Center of Excellence at St. John Providence Health System near Detroit, USA, 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 enrol 100 subjects at up to 15 investigational centres in the USA. 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.
SSO2 therapy is intended to provide interventional cardiologists with a 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 own blood, delivered through a catheter to the targeted ischaemic area of the heart. SSO2 therapy is intended to salvage the jeopardised myocardium and thus reduce infarct size. Multiple peer-reviewed studies have demonstrated the infarct size reduction achieved by SSO2 therapy as clinically significant compared to PCI alone.
“This study moves us another step closer to our goal of improving treatment options in the USA for physicians to provide to their heart attack patients,” says Kevin T Larkin, president and chief executive officer of TherOx.