ZOLL Medical receives FDA IDE approval for ISO Shock study


ZOLL Medical Corporation has announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for a randomised 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.

Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy to reduce infarct size resulting from high-risk heart attacks such as LAD-STEMI by delivering hyperoxemic levels of dissolved oxygen (7–10x normal) directly to damaged heart muscle immediately after percutaneous coronary intervention (PCI).

The ISO SHOCK study will determine the safety and feasibility of delivering SSO2 Therapy to patients presenting with STEMI and cardiogenic shock, a subset of high-risk patients with a mortality rate between 40‒60%, compared to standard practice and outcomes demonstrated in the National Cardiogenic Shock Initiative (NCSI).

“Cardiogenic shock remains one of the most challenging diagnoses for interventional cardiologists to manage, especially in the setting of STEMI,” said William O’Neill, cardiologist at Henry Ford Health System and co-investigator of ISO SHOCK along with M Babar Basir. “I have utilised 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.”

The ISO SHOCK study will randomise 60 patients in 20 sites across the USA 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 three to seven days after PCI.

“SSO2 Therapy was designed to recover damaged myocardium in heart attack patients, with the intention of preventing devastating heart failure and potentially death,” added Neil Johnston, president of ZOLL Circulation. “The initiation of the ISO SHOCK trial for the sickest of these patients —those in cardiogenic shock—only reinforces our commitment to this cause.”


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