The issue of faulty Automated Impella Controllers was elevated to a class I recall by the FDA, following five serious injuries. The agency also revised the label for fenofibrates to remove language ...

Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death. The issue stems from a manufacturing defect in certain units’ pump driver ...

When Zena Catalano began experiencing unusual fatigue last fall, a fleeting thought went through her mind: “A virus can affect the heart, right?” Catalano, 46, of Chesterfield Township, did not ...

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...

WAILUKU (HawaiiNewsNow) - The world’s smallest heart pump has made its way to Maui. Nine months after launching at Maui Memorial Medical Center, the island’s only acute-care hospital, it has saved ...

Impella heart pump upgraded to Class 2a in ACC/AHA treatment guideline for cardiogenic shock secondary to STEMI DANVERS, Mass., March 27, 2025 /PRNewswire/ -- Johnson & Johnson MedTech, the global ...

Use of two high-risk cardiovascular devices—the Watchman (Boston Scientific) left atrial appendage occluder and the Impella (Abiomed) left ventricular assist device—is highest in the United States ...

Antonia Haynes is a Game Rant writer who resides in a small seaside town in England where she has lived her whole life. Beginning her video game writing career in 2014, and having an avid love of ...

Impella 5.5 and Impella CP are the first left-sided, minimally invasive temporary mechanical circulatory support options for pediatric patients with symptomatic ADHF and cardiogenic shock DANVERS, ...

A new life-saving technology was used during a heartfelt reunion thanks to the world’s smallest heart pump, Impella, giving patients a second chance at life ...

The pivotal investigational device exemption (IDE) study, which enrolled 256 patients at 18 sites in the US, met the primary endpoint. MACCE (Major Adverse Cardiac and Cerebrovascular Events) rate at ...

Results were presented at Transcatheter Cardiovascular Therapeutics, or TCT, 2024 conference from the first completed pivotal trial on patients supported with Impella ECP, a novel transvalvular axial ...