The US Food and Drug Administration (FDA) has accepted TherOx’ Premarket Approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system.
The second-generation system is designed to reduce infarct size and thereby improve outcomes in anterior acute myocardial infarction (AMI)patients treated within six hours of symptom onset.
The system delivers a one-time, 60-minute infusion of superoxygenated blood to the coronary arteries after standard-of-care treatment for heart attack has been completed.
Although percutaneous coronary intervention (PCI) is the standard of care in treating AMI, for many patients it does not 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 ischaemic area of the heart through a small catheter. Adjunctive to PCI, SSO2 Therapy is intended to salvage heart muscle and reduce infarct size.
The PMA application includes data from the IC-HOT (Evaluation of Intracoronary Hyperoxemic Oxygen Therapy) study. This confirmatory study enrolled 100 patients at 15 investigational centres in the USA. The primary objective of the IC-HOT study was to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in the treatment of anterior ST-elevation AMI patients who have undergone successful PCI with stenting within six hours of experiencing AMI symptoms.
SSO2 study results
Results for the company’s confirmatory study of the first-generation SSO2 system were presented back in 2013. Shukri David (Detroit, USA) reported the data at the annual Transcatheter Cardiovascular Therapeutics meeting (TCT; 27 October–1 November, San Francisco, USA). Circulation: Cardiovascular Interventions published also the data.
“The SSO2 Therapy system has the potential to provide interventional cardiologists with the first treatment option beyond angioplasty and stenting to save substantially more heart muscle in heart attack patients than the current state-of-the-art treatment,” says Kevin T Larkin, president and chief executive officer of TherOx.
In the USA, SSO2 Therapy is delivered by an investigational device. It is limited by US law to investigational use. It is not for sale or distribution in the country.