Impella RP®

The only percutaneous, single vascular access pump approved for right heart support

Overview

The Impella RP heart pump is the world’s first and only percutaneous FDA-approved device for right heart support.

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®

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.1 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 within 48 hours of cardiogenic shock onset.1

 

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

Accessories

Additional Resources

Impella RP system with the Automated Impella Controller

View PDF

Impella RP system with the Automated Impella Controller with instructions for COVID-19 Emergency Use Authorization

View PDF

Patient selection recommendations and optimal timing

View PDF

Safety Information

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.

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 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. Anderson, M., et al., (2017). The Journal of Heart and Lung Transplantation, 36(4), S64-S65.
  2. Anderson, M., et al., (2015). The Journal of Heart and Lung Transplantation, 34(12), 1549-1560.

IMP-1704