Two separate randomized trials of Johnson & Johnson’s miniaturized Impella heart pumps failed to illustrate the devices’ benefits, spanning specific cases in patients with blockages in their coronary ... Yahoo: FDA posts early alert for safety issue with Impella heart pump devices FDA posts early alert for safety issue with Impella heart pump devices Johnson & Johnson MedTech’s Abiomed division has another serious recall on its hands stemming from its line of miniaturized Impella heart pumps, following reports that the devices could pierce and cut ... SALT LAKE CITY, /PRNewswire/ — In a transformative recent study, the Second Heart Assist Inc.
Whisper™ device, a next-generation percutaneous mechanical circulatory support (pMCS) ... MedTech Dive: J&J’s Impella heart pump shows no patient benefit in 2 trials Study investigators cautioned against routine use of the device in complex percutaneous coronary interventions and to treat heart attack patients who don’t have cardiogenic shock. 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 ...
