May 13, 2021 – ZOLL Medical Corporation (Chelmsford, MA), an Asahi Kasei company, announced today the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for a randomized prospective study evaluating the use of TherOx SuperSaturated Oxygen (SSO2) Therapy in patients presenting with ST Elevation Myocardial Infarction (STEMI) and cardiogenic shock and treated concurrently with a mechanical circulatory support device.
The ISO SHOCK study will assess the safety and feasibility of SSO2 Therapy in patients with this complex and highly fatal condition and potentially lay the groundwork for future trials to benefit high-risk heart attack patients, the company said.
The ISO SHOCK study will randomize 60 patients in 20 sites across the U.S. to assess whether SSO2 Therapy could provide benefit to these complex patients compared to the current standard of care. The primary safety endpoint will assess mortality at 30 days with the SSO2 Therapy group compared to the control group as well as against the historical 32% mortality from the NCSI. The feasibility endpoints will measure completion of a 60-minute SSO2 infusion after successful PCI, and obtaining an MRI 3–7 days after PCI.
SuperSaturated Oxygen (SSO2) Therapy is the first and only FDA-approved treatment to significantly reduce cardiac muscle damage in heart attack patients after percutaneous coronary intervention.1 It is currently indicated for patients who suffer LAD STEMI and are treated within six hours of symptom onset.
SSO2 Therapy was developed by TherOx, Inc. (Irvine, CA), now part of ZOLL Medical Corporation.