The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfusedby the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stentingthat 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.
A sterile, long and thin flexible tube inserted percutaneously into the vasculature and connected to a supersaturated oxygen (SSO2) therapy system for the infusion of autologous blood mixed with an SSO2 solution (producing oxygen-enriched hyperoxaemic blood) to a targeted coronary artery. It is typically an over-the-wire (OTW) catheter with a radiopaque marker band for fluoroscopic visualization. This is a single-use device.
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