How the Impella 2.5™ Works
The Impella 2.5 pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta.
The pump can be inserted via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the valve and into the left ventricle.
Indications For Use
The Impella 2.5™ System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
The Impella 2.5™ System also is indicated for short term use (≤ 4 days) 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 (including volume loading and use of pressors and inotropes, with or without IABP). The intent of treatment with Impella 2.5™ is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
Important Risk Information for Impella 2.5™
The Impella 2.5™ is contraindicated for use with patients experiencing any of 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)
- Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2)
- Severe peripheral arterial disease precluding placement of the Impella 2.5™ System
- Significant right heart failure*
- Combined cardiorespiratory failure*
- Presence of an Atrial or Ventricular Sepal Defect (including post-infarct VSD)*
- Left ventricular rupture*
- Cardiac tamponade*
* This condition is a contraindication for the cardiogenic shock indication only.
Potential Adverse Events
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella 2.5™. Visit www.protectedpci.com/hcp/information/isi and www.cardiogenicshock.com/hcp/information/isi to learn more.« back to top