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# TherOx SuperSaturated Oxygen Heart Therapy OK’d
- URL: https://www.fdaweb.com/therox-supersaturated-oxygen-heart-therapy-okd/
- Published: 2019-04-04T12:00:00.000Z
- Updated: 2026-09-15T01:18:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143796

FDA has approved a TherOx PMA for its SuperSaturated Oxygen (SSO2) Therapy that is intended to provide interventional cardiologists with a treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in heart attack patients. The therapy delivers hyperbaric levels of oxygen directly to ischemic heart muscle immediately after the coronary artery has been successfully opened by PCI (angioplasty and stenting). It is indicated, according to TherOx, for patients who suffer the most serious kind of heart attacks, left anterior descending ST-elevation myocardial infarction (also known as the widowmaker) treated within six hours of symptom onset. SSO2 Therapy is adjunctively administered immediately following successful stent placement, with no delay in PCI treatment, the company says.

TherOx says the SSO2 Therapy has been shown in multiple randomized prospective clinical trials to consistently and safely reduce infarct size in anterior acute myocardial infarction patients and thereby improve outcomes. “A pivotal randomized controlled trial demonstrated a 26% relative reduction in infarct size compared to PCI alone, it says. “Infarct size reduction correlates strongly with reduction in future complications, including heart failure, hospitalizations and even death.”

SSO2 Therapy is designed to infuse superoxygenated blood to improve microvascular flow and has been shown to save heart muscle by reducing infarct size, TherOx says. The superoxygenated blood helps reduce capillary swelling to restore blood flow to surrounding tissue and decrease infarct size, it says.