Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Exclusion Criteria

• •Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis.
• •Patient with oxygen saturation \< 90% (pulse oximeter/arterial) at the planned time of device placement (uncorrected by oxygen supplementation or intubation).
• •Sustained VT (at the time of the enrollment).
• •Significant right heart failure/right ventricular dysfunction.
• •Awake patient who is unable to remain in a stable recumbent position due to restlessness or lack of cooperation for other reasons.
• •Hypertrophic obstructive cardiomyopathy.
• •Left ventricular thrombus.
• •Subjects with a placed IABP.
• •Mitral and/or aortic valve prothesis, or more than mild native mitral or aortic valve stenosis.
• •Aortic valve insufficiency ≥ 2+ (on a 4-grade scale).
• •Mechanical complication of myocardial infarction (e.g., ventricular septal rupture, papillary muscle rupture) or evidence of uncorrected Ventricular Septal Defect or Atrial Septal Defect (VSD/ASD).
• •Brain damage (e.g., anoxic) or suspected brain damage.
• •Stroke or transient ischemic attack within the past 3 months.
• •Uncorrectable abnormal coagulation parameters (defined as platelet count \< 100,000 or INR \> 2.0 or fibrinogen \< 1.5 g/L) or active uncontrolled bleeding.
• •Allergy, sensitivity or intolerance to heparin, aspirin, Adenosine Diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia.
• •Known allergy, sensitivity or intolerance to nickel.
• •Known or suspected severe lung disease.
• •Evidence of any vascular disease that would preclude placement of the device (e.g., severely calcified and stenosed ilio-femoral vessels).
• •Aortic pathology, such as aortic aneurysms, extreme tortuosity, or calcifications that could pose an undue additional risk to the placement of a pLVAD device.
• •Any known or suspected disorder causing fragility of blood cells or hemolysis.
• •Subject participation in another investigational drug or device trial (post-market registries may be approved by Magenta Medical).
• •Life expectancy \< 1 year due to comorbidities.