FDA Approves TherOx SuperSaturated Oxygen Therapy to Reduce Infarct Size After PCI in AMI Patients
April 4, 2019—TherOx, Inc. announced FDA premarket approval for its SuperSaturated Oxygen (SSO2) therapy, which provides interventional cardiologists with a treatment for acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) to significantly reduce muscle damage in patients with AMI. The therapy is indicated for patients with left anterior descending ST-segment elevation myocardial infarction (LAD STEMI), treated within 6 hours of symptom onset.
According to the company, SSO2 therapy is adjunctively administered immediately after successful stent placement, with no delay in PCI treatment. The therapy delivers hyperbaric levels of oxygen directly to the ischemic heart muscle immediately after the coronary artery has been successfully opened.
SSO2 therapy delivers a one-time, 60-minute infusion of the patient’s super-oxygenated blood to the targeted ischemic area of the heart through a small catheter. The super-oxygenated blood helps reduce capillary swelling to restore blood flow to the surrounding tissue and decrease infarct size. SSO2 therapy is aligned with current guidelines for interventional cardiology procedures, advised the company.
TherOx stated that multiple randomized prospective clinical trials have shown that SSO2 therapy consistently and safely reduces infarct size in patients with anterior AMI and thereby improve outcomes.
In the TherOx announcement, Gregg W. Stone, MD, commented, “Even after angioplasty with stenting, many heart attack patients suffer from irreversible damage to the heart muscle, which carries a poor prognosis in terms of mortality and the potential for future heart failure. SuperSaturated Oxygen is the only therapy shown in a pivotal randomized trial to reduce infarct size in patients with large anterior myocardial infarction, offering the potential to further improve outcomes in these high-risk patients despite successful primary angioplasty.”