Impella RP Flex™
Overview
Impella RP Flex with SmartAssist is the only right heart pump equipped with dual-sensor technology to assist with pump management.
This technology pumps blood from the superior vena cava, superior atrial junction or right atrium (IJ insertion) or inferior vena cava (femoral insertion) to the pulmonary artery. The pump is inserted with venous access and advanced over a wire into the pulmonary artery using standard catheterization techniques.
- Provides circulatory assistance for up to 14 days in certain patients with a body surface area ≥ 1.5 m
- Delivers flow of greater than 4.0 L/min of blood
- Enables biventricular support when the left side is already supported with a left-sided Impella®
Right Heart Failure
During right heart failure, blood begins to backup because it isn’t adequately pumped out to the lungs. This backup causes pressure in the veins, resulting in swelling of the legs and ankles. Ultimately, the amount of blood reaching the lungs, where blood normally becomes infused with much-needed oxygen, is reduced.
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Indications for Use
The Impella RP® System, Impella RP® with SmartAssist® and Impella RP Flex™ with SmartAssist® are 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 System, Impella RP with SmartAssist and Impella RP Flex with SmartAssist are 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 the Impella RP System, Impella RP with SmartAssist and Impella RP Flex 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-5246