Impella RP Flex™

with SmartAssist®

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 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 

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. 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.2

  • 73%

    Survival rate for patients treated with Impella RP in the RECOVER RIGHT Studies*3

  • 70%

    Survival rate for patients treated with Impella RP in the PAS2

Impella Case Studies

Use of RP Flex for AMI STEMI Cardiogenic Shock

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Impella RP Flex™ with SmartAssist™ Following Impella 5.5® with SmartAssist® Placement: BiPella

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Impella RP Flex™ with SmartAssist® for Right Heart Failure Secondary to Valvular Heart Disease

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Use of RP Flex for Right Heart Support During Complex Mitral Repair and CABG

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Use of RP Flex for Acute Right Heart Failure Following Durable VAD Implantation

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Accessories

Impella RP Flex withSmartAssist
Automated Impella Controller
RP Flex Introducer Kit
.027”x260cm Placement Guidewire
Purge Cassette

Additional Resources

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

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

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Impella RP with SmartAssist System with the Automated Impella Controller

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Safety Information

PMA Approved Indication

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 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.

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 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.

Potential Adverse Events

The potential adverse effects (eg, complications) associated with the use of Impella RP 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.

Footnotes

  1. Lala, A., et al., (2018). J Card Fail, 24(3), 148-156.
  2. Impella RP System PMA Post-Approval Study Final Report.
  3. Anderson, M., et al., (2018). The Journal of Heart and Lung Transplantation, 37(12), 1448-1458.

 

*RECOVER RIGHT + CAP + HDE PAS

Survival to 30 days after device explant or hospital discharge (whichever was longer), or to the start of next longer-term therapy.

IMP-5060

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