Physicians use mechanical ventricular assist devices to support patients through periods of hemodynamic instability. Ventricular assist devices used for short-term support are usually brought into the patient through minimally invasive methods, mostly by accessing blood vessels in the groin (percutaneous delivery). In particular, these catheter-based devices are used in cardiogenic shock patients and patients undergoing high-risk cardiac or coronary procedures (high-risk PCI). The addressable market for minimally invasive ventricular assist devices is estimated at over 5 billion dollars, with an estimated 300.000 eligible patients annually.
Every 15-20 seconds, someone has a heart attack (acute myocardial infarction), translating to an estimated 2 million heart attacks in Europe and the US every year. In about 5-8% of heart attack sufferers, the myocardial infarction is complicated by cardiogenic shock. Cardiogenic shock is a medical emergency characterized by the inability of the heart to pump sufficient blood volume for adequate organ and tissue perfusion. Only about half of the patients suffering from cardiogenic shock survive their hospital stay - despite support with currently available ventricular assist devices.
Percutaneous coronary procedures allow the minimally invasive treatment of coronary artery disease. These procedures are a mainstay of interventional cardiology and usually uneventful. However, an estimated 5% of these procedures carries an elevated risk either due to the physiological or anatomical condition of the patient, or the complexity of a particular procedure (high-risk PCI). High-risk PCI procedures arrant the use of percutaneous ventricular assist devices to stabilize hemodynamics and protect patients throughout the procedure.