The TherOx DownStream® System
The DownStream System includes three device components: The DownStream System (console), DownStream Cartridge and SSO2 Catheter. Together these components create and deliver SuperSaturated Oxygenated (SSO2) Therapy to the patient following acute heart attack.
The console is a mobile hardware device that controls Cartridge operation. The cartridge is a disposable component that creates superoxygenated saline using hospital saline and oxygen, and then continuously mixes it to create superoxygenated blood. The SSO2 Catheter is a 5F (O.D.) over-the-wire catheter that delivers the superoxygenated blood into the left main coronary osmium using the femoral access site.
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. The TherOx DownStream System is 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.