The Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ catheters, in conjunction with the Automated Impella Controller, are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0 and LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
* Optimal medical management and convention treatment measures include volume loading and use of pressors and inotropes, with or without IABP.
Acute renal dysfunction, Aortic valve injury, Bleeding, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Renal failure, Thrombocytopenia and Vascular injury
The institution of circulatory support using Impella has not been studied in the following conditions: presence of irreversible end-organ failure; and presence of severe anoxic brain injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with the use of Impella in this indication. Visit www.cardiogenicshock.com/isi to learn more.
The Impella devices are contraindicated for use in this indication for patients experiencing the following conditions:
Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less (with respect to the Impella 2.5)) or (graded as ≥ +2 equivalent to an orifice area of 1.5 cm2 or less (with respect to the Impella CP, Impella 5.0 and Impella LD)); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure; Combined cardiorespiratory failure; Ongoing CPR; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD); Left ventricular rupture; and Cardiac tamponade.