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October 9, 2020

What Causes Thrombus Formation Among Blood-Contacting Medical Devices and What Can Be Done to Prevent Thrombosis?

This FAQ addresses thrombus formation and anticoagulation for blood-contacting medical devices, such as the Impella® heart pump.

August 25, 2020

What is the PROTECT Series?

This FAQ discusses the PROTECT series of FDA clinical studies, which include the PROTECT I study, the PROTECT II randomized controlled trial, and the PROTECT III study. 

July 7, 2020

How is Impella CP® with SmartAssist® different from Impella CP®?

This FAQ describes the Impella CP with SmartAssist and how it differs from the Impella CP heart pump.

April 16, 2020

What is the Difference Between “Venting” and “Unloading”?

Navin Kapur, MD succinctly explains the concept of ventricular unloading.

February 24, 2020

Amin et al. 

The objective of the analysis, as stated in Amin et al., was “to describe the trends in Impella® use; variation in Impella use and its outcomes over 13 years.

February 21, 2020

Dhruva et al. 

Dhruva et al. is a retrospective, observational analysis of patients with acute myocardial infarction (AMI) complicated by cardiogenic shock undergoing percutaneous coronary intervention (PCI) between October 1, 2015 and December 31, 2017. 

February 10, 2020

Is There Randomized Controlled Trial Data Available for Impella® Heart Pump Use in Cardiogenic Shock?

Abiomed is committed to providing the best possible clinical care and evidence of beneficial effect of Impella in critically ill patients with cardiogenic shock.

November 15, 2019

How Do Bleeding Rates with Impella® Compare to Bleeding Rates Associated With Other Forms of Mechanical Circulatory Support?

Data from the PROTECT II randomized controlled trial show that patients treated with Impella had numerically lower rates of vascular complications compared with patients treated with intra-aortic balloon pump (1.4% for Impella versus 1.9% for IABP).1

August 2, 2019

Right Heart Failure and the Impella RP® Heart Pump

This FAQ discusses the causes, incidence, and diagnosis of right heart failure and how the Impella RP(R) heart pump can support the right side of the heart.

August 2, 2019

What is the STEMI DTU™ Pivotal Trial?

The STEMI DTU pivotal trial is a prospective, multicenter, two-arm randomized controlled trial that plans to enroll 668 patients undergoing treatment for a STEMI heart attack. 

July 9, 2019

What is the purpose of the STEMI DTU™ RCT?

The pivotal trial will build on the promising results of the successful STEMI DTU safety and feasibility trial, or STEMI DTU pilot trial, which met its goal by demonstrating it is safe and feasible to conduct

June 19, 2019

What Is the Real-World Evidence That Supports the Benefit of Placing the Impella® Heart Pump Pre-PCI?

A preponderance of evidence from the FDA cVAD Study, Impella Quality Assurance Database and physician-initiated National Cardiogenic Shock Initiative support the recommendation that placing Impella 2.5 or Impella CP pre-PCI improves outcomes.

November 5, 2018

What is NCSI Study?

The NCSI Study is based on adopting the best practices algorithm focused on identifying shock early and unloading using Impella devices before PCI, reducing use of inotropes, and the use of invasive hemodynamic monitoring to aid in escalation and weaning.

November 5, 2018

What is the STEMI DTU Pilot Trial?

The STEMI DTU pilot trial demonstrated for the first time that LV unloading using the Impella CP® heart pump with a 30-minute delay before reperfusion is safe and feasible

November 5, 2018

What is A-CURE?

The clinical, preclinical, and basic research of A-CURE focuses primarily on the use of the Impella® heart pump, a transvalvular microaxial flow pump, as the means to unload the heart.