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US Device Guide / Super Saturated Oxygen Therapy

Company Name Product Name Specifications Comments US FDA Indicated Use
TherOx Inc. DownStream Cartridge DownStream cartridge The cartridge is a disposable component that creates superoxygenated saline using hospital saline and oxygen, and then continuously mixes it with the patient’s blood to create superoxygenated blood Indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion
TherOx Inc. DownStream Console A/C power with battery back-up The DownStream console monitors performance and safety during administration of SSO2 Therapy; includes a display screen and utilizes in-hospital saline and oxygen for operation Indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion
TherOx Inc. SSO2 Catheter 5 F; FL 3.5, FL 4.0, FL 4.5, FL 5.0 The SSO2 Catheter is a 5-F (OD) over-the-wire catheter that delivers superoxygenated blood into the left main coronary ostium using a femoral access site Indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion

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