August 17th, 2016
An in-depth clinical review of cardiogenic shock case studies, clinical trial data, outcomes, use in various patient populations, and cost-effectiveness.Download
April 8th, 2016
New U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart.
Impella provides hemodynamic stability and can reverse this cycle by1,2,3,4,5:
Unloads Left Ventricle1,
End Organ Perfusion3,4
Right Side Support5
Escalation & Ambulation
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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.
In connection with the above indications, the Impella devices are contraindicated for use in 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); Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥ +2); Severe peripheral arterial disease that precludes the placement of the Impella System; Significant right heart failure; Combined cardiorespiratory failure; Presence of an Atrial or Ventricular Sepal Defect (including post-infarct VSD); Left ventricular rupture; and Cardiac tamponade.
Additionally, potential for the following risks has been found to exist with use of the Impella devices in the above indications: 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.