Impella RP®
The Impella RP with SmartAssist heart pump provides temporary, circulatory support for patients who develop right heart failure. Impella RP with SmartAssist is indicated for patients experiencing acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.
Right Heart Failure
Right heart failure (RHF) is a condition that occurs when the right side of the heart can't pump blood efficiently. It's often caused by left ventricular failure which results in fluid build up and high pressure in the lungs. The elevated pulmonary pressure increases the workload of the right ventricle leading to RHF. RHF can also be caused by damage directly to the right ventricle, such as in a heart attack involving the right coronary artery.
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Indications for Use
The Impella RP® with SmartAssist® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.
The Impella RP with SmartAssist System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP devices. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22Fr catheter.
The potential adverse effects (eg, complications) associated with the use of Impella RP with SmartAssist: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.
IMP-1698