DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market ...

CLEVELAND — Forty-one-year-old Mark Kader is a husband, father of five, registered nurse, and associate clinical consultant for Abiomed, a medical device company. He's passionate about educating ...

NEW ORLEANS – The Impella 5.0 and 5.5 left ventricular assist device failed to measure up on outcomes when used for high-risk patients undergoing ventricular tachycardia (VT) ablation therapies, ...

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 ...

For patients who have acute MI with cardiogenic shock (AMICS), Medicare claims data aren’t detailed enough to show whether use of the Impella percutaneous microaxial left ventricular assist device ...

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 first three patients in the world have been treated with Impella RP Flex with SmartAssist, Abiomed’s newest heart pump for ...

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 ...

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 ...

The FDA typically requires post-approval studies for medical devices that receive a PMA, the FDA’s highest level of regulatory approval. FDA post-approval studies use high-quality prospective data to ...