Zoll IDE for TherOx SuperSaturated Oxygen Study

FDA has approved a Zoll Medical IDE for a randomized prospective study evaluating the use of TherOx SuperSaturated Oxygen Therapy in patients presenting with ST Elevation Myocardial Infarction (STEMI) and cardiogenic shock and treated concurrently with a mechanical circulatory support device. Patients presenting with STEMI and cardiogenic shock typically have a mortality rate of 32%, the company says.

The ISO SHOCK study will randomize 60 patients in 20 sites across the U.S. to assess whether TherOx could provide benefit to the complex patients compared to the current standard of care, the company says. The primary safety endpoint will assess mortality at 30 days with the TherOx group compared to the control group as well as against the historical 32% mortality rate.

The device is FDA approved to significantly reduce cardiac muscle damage in heart attack patients after percutaneous coronary intervention.