First Patient Enrolled in AMIHOT III Trial Investigating ZOLL’s Supersaturated Oxygen Therapy in Heart Attack Patients
Study Evaluates the Effectiveness of TherOx Supersaturated Oxygen (SSO2) Therapy in Patients Presenting with Acute Anterior Myocardial Infarction with Successful Reperfusion Compared to Standard Therapy
Excerpt from the Press Release:
CHELMSFORD, Mass.–(BUSINESS WIRE)–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.
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