The results challenge the rapid growth of Impella support during high-risk PCI. Investigators say a reckoning is needed.
Two separate randomized trials of Johnson & Johnson’s miniaturized Impella heart pumps failed to illustrate the devices’ ...
In the STEMI Door-to-Unload trial, use of Impella missed the mark in patients with anterior MI without cardiogenic shock.
Randomized trials neutral for pump device in complex elective cases, STEMI with reperfusio ...
Johnson & Johnson’s Abiomed has asked customers to quarantine certain Impella devices over a risk linked to four serious injuries, the Food and Drug Administration said Wednesday. Abiomed wrote to ...
Add Yahoo as a preferred source to see more of our stories on Google. The Food and Drug Administration issued an early alert for a correction of Abiomed's Impella RP Flex heart pumps. (Courtesy of ...
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 ...
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 ...
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 ...