Impella RP®

A minimally invasive, right-sided heart pump with a flow rate greater than 4.0 L/min
 

Overview

The Impella RP heart pump provides temporary, circulatory support for patients who develop right heart failure. It is the only FDA-approved heart pump indicated for patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infraction, heart transplant or open-heart surgery.

After six days of Impella® support, Nancy Wilkins was able to return home.

The Impella RP heart pump had been implanted to assist the pumping function of Nancy's heart to allowing it to rest and recover.

Are you a health care professional?

Visit heartrecovery.com to access instructions for use and other clinical materials.

Indications for Use

Cardiogenic Shock

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.

Emergency Use Authorization

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.

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.

Potential Adverse Events

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.

IMP-1698