Overview
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Take a CME course: "Reduction in Infarct Size with SSO2 Therapy." |
TherOx conducted the pivotal AMIHOT II trial to evaluate the safety and effectiveness of SSO2 Therapy to treat Acute Myocardial Infarction (AMI) in anterior wall infarction patients treated with PCI and stenting within 6 hours of symptom onset. Investigational centers in the United States, Europe, and Canada participated in the FDA-sanctioned trial.
TherOx had conducted previous clinical evaluations of SSO2 Therapy to treat AMI, first in a Phase I feasibility study (29 subjects), and then in the randomized AMIHOT I study (269 subjects). The AMIHOT I study included all patients with inferior and anterior wall heart attacks within 24 hours of symptom onset. The results of these earlier studies suggested improvements in heart function and viability in subjects treated with SSO2 Therapy. Learn more about the results from the earlier studies.
The goal of the AMIHOT II study was to validate these earlier promising results in patients with anterior wall heart attacks treated with PCI within 6 hours of symptom onset. The study included 301 patients. Find out more about the results of the AMIHOT II study.
DISCLAIMER
Europe: The TherOx® DownStream® System, the TherOx® DownStream® Cartridge, and the TherOx® AO Catheter bear the CE Mark and are available for sale in Europe.
United States: In the United States, the TherOx® DownStream® System, the MI-Cath® Infusion Catheter, and the DownStream® AO Cartridge, are investigational devices. They are limited by United States law to investigational use. They are not for sale or distribution in the United States.
