FDA Grants Approval to TherOx for Supersaturated Oxygen Therapy in LAD STEMI
When delivered within 6 hours of symptom onset, the therapy has been shown to reduce infarct size more than primary PCI alone.
The US Food and Drug Administration (FDA) has approved SuperSaturated Oxygen (SSO2) Therapy to reduce infarct size in patients with left anterior descending (LAD) STEMI, the manufacturer, TherOx, announced today.
The therapy involves mixing highly oxygenated saline with the patient’s own blood and then infusing the superoxygenated mixture via catheter directly to the damaged heart muscle after PCI.
Two clinical studies, AMIHOT II and IC-HOT, showed the therapy to be safe and effective. In AMIHOT II, SSO2 Therapy demonstrated a 26% median reduction in infarct size compared with PCI and stenting alone. Other clinical trial data have shown left ventricular stability at 30 days with no deleterious enlargement.
TherOx. TherOx receives FDA approval for first heart attack treatment since PCI to reduce infarct size. Published on: April 4, 2019. Accessed on: April 4, 2019.