Impella®
Impella®
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Impella®
The World's Smallest Heart Pump

The first percutaneous, single vascular access pump designed for right heart support

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Impella RP®

How It Works:

 The Impella RP heart pump delivers blood from the inlet area, which sits in the inferior vena cava, through the cannula to the outlet opening near the tip of the catheter in the pulmonary artery. The pump can be inserted through a standard catheterization procedure via the femoral vein, into the right atrium, across the tricuspid and pulmonic valves, and into the pulmonary artery.

Insertion:

 The Impella RP can be inserted through a standard catheterization procedure through the femoral vein and into the right atrium, to support a patient’s pulmonary circulation and provide hemodynamic stability.
Instructions for Use

Right Ventricular Dysfunction is Common in Patients with Cardiogenic Shock during Acute Myocardial Infarction

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In patients experiencing:

  • Right heart failure
  • Decompensation following left ventricular assist device implantation
  • Myocardial infarction
  • Heart transplant
  • Open-heart surgery

The Impella RP®:

  • FDA approved for right heart failure
  • Allows the patient’s heart to rest
  • Recovers the heart’s ability to pump blood

Indications for Use

The Impella RP® 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 following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Contraindications and Warnings

The Impella RP 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 device. 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 22 Fr catheter.

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Potential Adverse Events

Below is a list of the potential adverse effects (eg, complications) associated with the use of the Impella RP System: 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.