September 13, 2022 — ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the first patient has enrolled in the AMIHOT III post-approval study further evaluating TherOx SuperSaturated Oxygen (SSO2) Therapy for the treatment of the most severe form of heart attack, left anterior descending (LAD) ST-Elevation Myocardial Infarction (STEMI). The patient, treated at WakeMed Health & Hospitals in North Carolina, received SSO2 Therapy, the first FDA-approved therapy shown to significantly reduce the size of damaged tissue (infarct) following percutaneous coronary intervention (PCI).
Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy in reducing infarct size in LAD STEMI1,2,3 by delivering a high concentration of dissolved oxygen (7–10x normal) directly to damaged heart muscle immediately after stenting. TherOx SSO2 Therapy is currently indicated for patients who suffer LAD STEMI — heart attacks with a high mortality rate — treated within six hours of symptom onset. SSO2 Therapy has been shown to reduce relative infarct size — damage to the heart muscle — by 26% over standard of care. One year follow-up data on patients treated with SSO2 Therapy showed reductions in heart failure hospitalization and mortality.4
AMIHOT III is a randomized, post-approval evaluation that will further validate the benefits of SSO2 Therapy over current standard of care alone and provide insight into the mechanisms that lead to improved outcomes for LAD STEMI patients. Besides demonstrating the safety and effectiveness of SSO2 Therapy, additional endpoints include incidence of microvascular obstruction (MVO), and outcomes measures such as heart failure readmissions and quality-of-life measures. The study will randomize 434 patients across sites in the U.S. and Europe. The study’s Principal Investigator is James Blankenship, MD, MHCM, MSCAI (University of New Mexico, Albuquerque, NM).
“WakeMed strives to be on the cutting edge of cardiovascular care, and I am excited that our team has enrolled the first AMIHOT III patient in this study to further confirm SSO2 Therapy's benefits over standard of care in the treatment of severe heart attacks,” said Frances Wood, MD, interventional cardiologist at WakeMed. “Based on our experience with the IC-HOT trial that helped SSO2 achieve FDA approval, we believe this therapy will have a strong impact in improving outcomes and reducing mortality for heart attack patients.”5
“With SSO2 Therapy, ZOLL is expanding care for LAD STEMI patients,” added Christopher Barnabas, President of ZOLL Circulation. “Previous data serve as a strong indication that we will observe short- and long-term outcome improvements such as reduced incidence of heart failure and mortality in these high-risk patients.”1,2,3,4
For more information: www.zoll.com
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 Chen, et al. Catheter Cardiovasc Interv. 2020;1–7.
5 David SW, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2018;1–9. https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.27905