The Impella RP with SmartAssist heart pump provides temporary, circulatory support for patients who develop right heart failure. The FDA-approved heart pump is indicated for patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.
FOR PATIENTS EXPERIENCING
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.
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 following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Only the Impella RP System is authorized to be used by healthcare providers (HCP) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to Coronavirus Disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb‐3(b)(1), unless the authorization is terminated or revoked sooner.
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 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.
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.
Visit www.abiomed.com/impella and to learn more.