Clinical Evidence


Overview
The Impella RP Flex is the smallest percutaneous and only intracorporeal right heart MCS when compared to other right-sided devices and is the newest device in the Impella RP product line. The Impella RP is the most studied right-sided device and the only percutaneous technology with FDA approval designating it as safe and effective for right-heart support. Its FDA approval is the result of more than nine years of clinical studies.
RECOVER RIGHT: Impella RP Safety & Efficacy
73% overall survival-to-discharge at 30 days1
All patients discharged were alive at 180 days1
Sustained hemodynamic improvement after Impella RP® support1
- Increase in cardiac index (CI)
- Decrease in central venous pressure (CVP)
- Fewer benchmark adverse events at 30 days1 compared to other RVAD studies
- Death, bleeding, hemolysis
- Neurologic dysfunction and limb ischemia
References
- Anderson, MB et al. (2015). Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP Device. The journal of Heart and Lung Transplantation, 34(12):1549-1560. DOI: 10.1016/j.healun.2015.08.018
NPS-1191