Impella® 2.5

Impella 2.5

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.

Indication for use

The Impella® 2.5 System (Impella® 2.5) is a temporary (< 6 hours) ventricular assist 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 that high risk PCI is the appropriate therapeutic option. Use of the Impella® 2.5 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.

Contraindications and Warnings

The Impella 2.5 is contraindicated for use with patients experiencing any of the following conditions:  (1) mural thrombus in the left ventricle; (2) Mechanical aortic valve or heart constrictive device; (3) Aortic valve stenosis/calcification (equivalent to an orifice of 0.6 cm2 or less); (4) Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); and (5) Severe peripheral arterial disease that precludes the placement of the Impella® 2.5

Additionally, potential for the following risks has been found to exist with use of the Impella 2.5:  Acute renal dysfunction; Aortic insufficiency; Aortic valve injury; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cardiopulmonary resuscitation; Cerebral vascular accident/Stroke; Death; Device malfunction; Failure to achieve angiographic success; Hemolysis; Hepatic failure; Insertion site infection; Limb ischemia; Myocardial infarction; Need for cardiac, thoracic or abdominal operation; Perforation; Renal failure; Repeat revascularization; Respiratory dysfunction; Sepsis; Severe hypotension; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack; Vascular injury; Ventricular arrhythmia, fibrillation or tachycardia.

Additional and important warning and risk information concerning the Impella 2.5 system can be found in the device’s instructions for use manual, by clicking here.

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