The U.S. Food and Drug Administration (FDA) has granted ZOLL Medical investigational device exemption (IDE) for a randomized study to evaluate TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients with cardiogenic shock and ST Elevation Myocardial Infarction (STEMI) treated simultaneously with a mechanical device for circulatory support. The ISO (Incorporating Supersaturated Oxygen) Shock study will efficacy and safety of SSO2 Therapy. William O’Neill, MD, Cardiologist at Henry Ford Health System and co-investigator of ISO SHOCK along with M. Babar Basir, MD., stated, “Cardiogenic shock remains one of the most challenging diagnoses for interventional cardiologists to manage, especially in the setting of STEMI. I have utilized SSO2 Therapy in previous trials for anterior STEMI and seen positive results, and I think there is a significant potential benefit for this high-risk population as well.”
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