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Many short-term cardiac assist devices are available, but these devices, such as veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and the extra-corporeal, percutaneous blood pumps, and intra-aortic balloon pumps, are associated with high rates of adverse events due to their invasive blood contact. These adverse events include stroke rates of 2 to 15%, renal dysfunction rates of 21% to 47% (and 12% rate of kidney failure for VA-ECMO), a 5 to 13% rate of hemolysis and 5% to 60% rate of bleeding at the femoral access sites leading to blood transfusions of 1L to up to 5 to 10L, depending on device, which can sensitize recipients against future transplants.  Furthermore, patients often require systemic anticoagulation therapy in association with these devices in order to reduce potential clotting complications, compounding the potential for, and magnitude of, hemorrhagic events. Up to 40% of patients cannot use existing devices due to peripheral arterial disease (PAD) which prevents the devices from being implanted, inability to receive anticoagulant therapy, or a need for biventricular support (vs. only left ventricular support).  The only biventricular cardiac assist device alternative, VA-ECMO, has high rates of adverse events.

Despite current best practices using existing short-term cardiac assist devices, acute heart failure is associated with high mortality rates – the death rate is approximately 10%, while 30% of patients will die within 1 year of discharge; thus, there is a large unmet need in effective therapeutic options for these patients.  Towards this end, CorInnova is commercializing a safer, non-blood contacting, minimally invasive biventricular device designed to increase cardiac output and provide ventricular unloading in acute HF patients requiring short-term cardiac assist.