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 ...

Abiomed (NASDAQ: ABMD) announces the results of PROTECT III, the ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. PROTECT ...

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 ...

After demonstrating last year that its miniaturized heart pumps could improve survival shortly after a serious heart attack, Johnson & Johnson MedTech has now shown that the benefits from its Impella ...

DANVERS, Mass.--(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart ...

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, part of Johnson & Johnson MedTech, has identified an issue that may affect the detection of its Impella pumps when connected to their controllers, according to an alert put out by the US Food ...

Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...

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 ...

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 ...

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 ...