Background: The Impella device provides percutaneous left ventricular support but may induce aortic regurgitation (AR) due to its transvalvular placement. In this study, we defined Impella-induced AR ...

The Impella heart pump is a small pump that a healthcare professional can insert without surgery. It can help maintain blood flow in people who have CAD, are recovering from cardiogenic shock, or are ...

Abiomed Inc. ABMD recently announced that its Impella 2.5 heart pump has received FDA Pre-Market Approval (PMA) for use in high risk percutaneous coronary intervention (PCI) procedures. Notably, ...

DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related ...

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety ...

The use of left-sided Impella microaxial flow pumps has expanded rapidly for the management of cardiogenic shock, left ventricular unloading and as a bridge to heart transplantation. However, standard ...

The Impella XR sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with the Impella 2.5 heart pump. It inserts at 10 French (Fr) and the flexible, ...

Abiomed, Inc.’s ABMD newest heart pump, the Impella 5.5 with SmartAssist, recently received FDA pre-market approval based on its safety and efficacy in the therapy of cardiogenic shock. Notably, the ...

Introduction: Impella and IABP are widely used temporary mechanical circulatory support (tMCS) devices in cardiogenic shock (CS). While Impella can be used as the initial support device or after IABP ...

According to the World Health Organization, diseases of the circulatory system, including heart disease such as heart attacks, are still among the most common causes of death worldwide. Recovering the ...

The FDA typically requires post-approval studies for medical devices that receive a PMA, the FDA’s highest level of regulatory approval. FDA post-approval studies use high-quality prospective data to ...