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 ...

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 ...

WASHINGTON, D.C.—Johnson & Johnson MedTech’s Abiomed announced that its compressible, expandable heart pump has cleared a pivotal trial, and it’s now headed for FDA review in the coming months. The ...

Johnson & Johnson’s (NYSE:JNJ) Abiomed has issued an Early Alert regarding its Automated Impella Controllers (AIC) for Impella heart pumps, a device crucial for patients with severe heart conditions.

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart ...

DANVERS, Mass. – October 24, 2024 – Novel data on the benefits of Impella ® heart pump technology in high-risk percutaneous coronary intervention (PCI) and cardiogenic shock will be presented during ...

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 ...

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 ...

Abiomed has issued an urgent medical device correction for its Impella RP and Impella RP Flex series of heart pumps. In a letter sent to customers on January 27, Abiomed said the voluntary device ...