Abiomed has reported eight instances of major bleeding, with three ‘contested’ patient deaths related to a leakage issue with its Impella introducer kits.
Routine use of the Impella CP microaxial flow pump did not improve outcomes and may have contributed to deaths among patients undergoing high-risk percutaneous coronary intervention (PCI), according ...
Abiomed, Inc. ABMD recently received FDA pre-market approval (PMA) for its newest right heart pump — the Impella RP with SmartAssist. The FDA has deemed the new pump as safe and effective when it ...
Impella CP with SmartAssist is the latest technological development for the Impella platform and is designed to improve patient outcomes with advanced algorithms and simplified patient management.
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 ...
In October 2019, the first U.S. patients were successfully treated by cardiac surgeons at Cleveland Clinic, Hackensack Meridian Health and Cedars-Sinai Medical Center. Since then, more than 120 ...
Impella heart pumps (Abiomed) provide procedural and hemodynamic benefits during high-risk PCI, but it’s difficult to assess whether they have an impact on clinical outcomes, particularly when ...
The Impella RP platform includes the world’s smallest percutaneous right heart mechanical circulatory support (MCS) technologies designed to help patients achieve native heart recovery. They do not ...
A new national study finds that use of the Impella circulatory support device is associated with higher rates of death and major bleeding than a common alternative, especially among patients with ...
Physicians forced to make rapid-fire choices, with limited evidence, in acute myocardial infarction complicated by cardiogenic shock (AMICS) finally have what they’ve long been waiting for: positive ...
A literature search was carried out for this briefing in accordance with the published process and methods statement. This briefing includes the most relevant and best publicly available evidence ...
Impella 2.5 is a miniaturised, catheter-based, intravascular blood pump that supports a patient's circulatory system. It provides continuous forward flow to increase overall cardiac output, unload ...