Illustration of a heart on the navy background with hash pattern overlay

Impella RP®

with SmartAssist®
The only percutaneous pump approved for right heart support with single vascular access, designed for intelligent patient management

Overview

Impella RP with SmartAssist is the only right heart pump equipped with dual-sensor technology to assist with pump management.

This technology pumps blood from the inferior vena cava 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 m2
  • 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®

FOR USE IN:

Right Heart Failure

37% of patients experience right ventricular failure when in cardiogenic shock.1 Impella RP with SmartAssist can support patients and may enable recovery.

Clinical Evidence

The prospective, multi-center FDA PMA post-approval study compared survival in patients who would have met enrollment criteria for the RECOVER RIGHT trial to those who would not have qualified for the trial because they were in cardiogenic shock for more than 48 hours.2 These results, from the Impella RP’s post-approval study, are similar to the survival rate in Impella RP’s pre-approval study, RECOVER RIGHT.3

  • 73%

    Survival rate for patients treated with Impella RP within 48 hours of cardiogenic shock onset.2

 

Navin Kapur, MD, shares an Impella RP case in which LV and aortic pressures increased after just a few heartbeats on support

Accessories

Additional Resources

Impella RP with SmartAssist System with the Automated Impella Controller

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Learn more about the features of the Impella RP with SmartAssist heart pump

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Impella RP Flex™ with SmartAssist System with the Automated Impella Controller

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Safety Information

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.

Emergency Use Authorization

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.

Contraindications and Warnings

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 with SmartAssist 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 22Fr 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.

Footnotes

  1. Lala, A., et al., (2018). J Card Fail, 24(3), 148-156.
  2. Anderson, M., et al., (2018). The Journal of Heart and Lung Transplantation, 37(12), 1448-1458.
  3. Anderson, M., et al., (2020). Early Impella RP Support Improves Outcomes for Acute Right Ventricular Failure Complicated by Cardiogenic Shock. Presentation, TCT Connect.

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