FDA Grants IDE Approval for Zoll’s ISO Shock Feasibility Study

ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced that 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.
 
Multiple clinical trials have demonstrated the efficacy of SSO₂ Therapy to reduce infarct size resulting from high-risk heart attacks such as LAD-STEMI^1,2,3 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 and 60 percent,⁴ compared to standard practice and outcomes demonstrated in the National Cardiogenic Shock Initiative (NCSI).
 
A STEMI heart attack is associated with a two-fold increased risk of developing cardiogenic shock,⁵ a life-threatening condition in which the heart cannot pump adequate oxygenated blood to vital organs. Cardiogenic shock represents the highest risk category of STEMI with the greatest myocardial damage from ischemia. SSO₂ Therapy could potentially mitigate damaged tissue while improving left ventricular structure and function in this complex patient population.
 
“Cardiogenic shock remains one of the most challenging diagnoses for interventional cardiologists to manage, especially in the setting of STEMI,” said William O’Neill, M.D., cardiologist at Henry Ford Health System and co-investigator of ISO SHOCK along with M. Babar Basir, M.D. “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.”
 
The ISO SHOCK study will randomize 60 patients in 20 sites across the United States 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 percent 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.”
 
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 Irvine, Calif.-based TherOx Inc., now part of ZOLL Medical Corporation.

References
¹ Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75
² O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405.
³ David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.
⁴ Kapur NK, et al. Methodist Debakey Cardiovasc J. 2020 Jan-Mar; 16:1:16–21.
⁵ Vahdatpour C, et al. J Am Heart Assoc. 2019 Apr 16;8:8:e011991.