TherOx has conducted several clinical studies to establish the safety and effectiveness of SSO2 Therapy. In total, nearly 800 patients have been clinically evaluated. The pivotal randomized AMIHOT I and II clinical trials demonstrated a 26% relative infarct size reduction and a non-inferior safety profile as compared to control subjects receiving the standard of care. Post hoc interpretation of subset data reveals an even more dramatic infarct size reduction benefit in patients with shorter times to reperfusion and better TIMI flow grade upon presentation.
Most recently TherOx completed the IC-HOT confirmatory study which included 100 patients at 15 U.S. centers. This study demonstrated results consistent with AMIHOT I and AMIHOT II studies, confirming safety with the latest generation SSO2 Therapy system.
Please visit our Publications page for more information on SSO2 Therapy data.
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