Longer times from symptom onset to randomization equaled a smaller—or perhaps no—advantage for Impella vs standard care.

After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall ...

The study demonstrated Impella ECP's safety and efficacy for use in high-risk PCI. Operators chose 8Fr Angio-Seal as the first-closure method in 70% of the patients, with a 92% success rate 1.

The FDA has opened up the use of Johnson & Johnson’s miniaturized heart pumps to certain pediatric patients, including those suffering from acute heart failure and cardiogenic shock. The agency ...

Abiomed has issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling does not fully address the precautions needed when ...

The US Food and Drug Administration (FDA)-approved labeling for the Impella 5.0 and Impella LD heart pumps (Abiomed) has been expanded to allow for longer support time in critically ill patients, the ...

Abiomed is recalling all Impella left-sided blood pumps in the US over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent ― something that is not ...

Impella, which J&J touts as the world’s smallest heart pump, has a range of devices used for various heart conditions. Lexeo ...

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company's investigational device exemption application to start ...

There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump's ...

DANVERS, Mass. – October 28, 2024 – Results were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2024 conference from the first completed pivotal trial on patients supported with Impella ...