Frequently Asked Questions
Welcome to the ProtectedPCI.com’s Frequently Asked Questions. Click on an category item below to find questions and answers on some commonly asked questions about the Impella device. Watch the videos for a quick summary, or click the links to take a deeper dive into the material.
Randomized Control Trials
- Is there randomized controlled trial data available for Impella® heart pump use in Cardiogenic Shock?
- What is NCSI?
- What is the STEMI-DTU Pivotal trial?
- What is the STEMI-DTU Pilot trial?
- What is the rationale for DTU-STEMI Pilot trial?
- What are the results and clinical implications of the DTU-STEMI Pilot trial?
- What is the purpose of the STEMI DTU RCT?
- What are the challenges with conduct of randomized trials in Cardiogenic shock?
- What is the published clinical evidence for Impella use in cardiogenic shock?
Real World Evidence
- How is hemolysis measured?
- How is Impella designed to minimize hemolysis?
- What factors most likely cause hemolysis with Impella in the clinical setting?
- How does the rate of hemolysis with Impella devices compare to other heart pumps in pre-clinical/bench testing?
- How does the rate of hemolysis with Impella devices compare to other heart pumps in clinical setting?