TherOx has received premarket approval from the Food and Drug Administration (FDA) for SuperSaturated Oxygen (SSO2) Therapy for use in patients who suffer left anterior descending (LAD) ST-elevation myocardial infarction (MI).
Specifically, the treatment is indicated for the preparation and delivery of supersaturated oxygen to targeted ischemic regions perfused by the patient’s LAD coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute MI symptoms caused by a LAD artery infarct lesion. Using in-hospital oxygen and saline and mixing it with the patient’s arterial blood, SSO2 delivers a one-time, 60-minute infusion of the superoxygenated blood through a small catheter.
The approval was based on data from several clinical trials. In a pivotal randomized controlled trial, a post-PCI infusion of SSO2 resulted in a significant reduction in infarct size (primary endpoint) compared with PCI alone. With regard to safety, the incidence of major adverse cardiovascular events (MACE) measured at 30 days was similar in both arms, indicating noninferiority between the 2 groups.
“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,” said Gregg W. Stone, MD, professor of medicine, Columbia University Medical Center. “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.”
SSO2 Therapy is delivered through the DownStream System which is comprised of 3 devices: the console, cartridge and catheter.
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