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August 19, 2021

FAQ: Anticoagulation

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

August 9, 2021

Study of 21,848 High-Risk PCI Patients Demonstrates Lower Risk of Death and Complications in Patients who Receive PVADs  

A study of 21,848 non-emergent, high-risk patients who underwent PCI with PVADs, including Impella® heart pumps, demonstrates the PVAD patients had a lower rate of mortality and complications than patients who underwent PCI with IABPs.

May 19, 2021

Intra-aortic Balloon Pump (IABP) FAQs

This FAQ discusses how IABP works and the role of IABP in Protected PCI and cardiogenic shock.

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. 

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. 

This FAQ explains how the conclusion of Amin et al. conflicts with more robust, previously published, FDA-audited, peer-reviewed, real-world studies and RCTs.

February 21, 2020

Dhruva et al. 

This FAQ explains how the conclusions of Dhruva et al. conflict with Impella® best practice outcomes reported in more robust, previously published, contemporary, prospective studies.

February 10, 2020

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

This FAQ discusses the challenges of obtaining RCT data for cardiogenic shock and presents the clinical data that is currently available and ongoing.

November 15, 2019

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

This FAQ discusses bleeding rates associated with mechanical circulatory support and vascular access and closure techniques for successfully managing bleeding.

August 2, 2019

Right Heart Failure and the Impella RP® with SmartAssist® Heart Pump

This FAQ discusses the causes, incidence, and diagnosis of right heart failure and how the Impella RP with SmartAssist 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?

This FAQ provides key information about the purpose and design of the STEMI DTU pivotal randomized controlled trial and how to participate.

June 19, 2019

FAQ: What Is the Clinical Evidence That Supports the Benefit of Placing the Impella® Heart Pump Pre-PCI?

A preponderance of evidence from the FDA cVAD Study, Impella Quality Database and the physician-initiated NSCI study supports 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

NPS-1674