More Impella left-sided blood pumps are under Class I recall, this time for potential interactions with transcatheter aortic valve replacement (TAVR) stents, the FDA announced Thursday. The affected ...
Use of two high-risk cardiovascular devices—the Watchman (Boston Scientific) left atrial appendage occluder and the Impella (Abiomed) left ventricular assist device—is highest in the United States ...
When he was 25 years old, Thorsten Siess, a mechanical engineering student at the University of Aachen in Germany had an idea: What if there was a way to keep the heart pumping blood during surgery or ...
Physicians forced to make rapid-fire choices, with limited evidence, in acute myocardial infarction complicated by cardiogenic shock (AMICS) finally have what they’ve long been waiting for: positive ...
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 ...
For Abiomed’s beleaguered family of Impella heart pumps, Class I recalls are becoming a monthly event. The devices have racked up their third recall in as many months, the latest of which focuses on ...
The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart. By Christina Jewett A troubled ...
DANVERS, Mass.--(BUSINESS WIRE)--Two studies of AMI cardiogenic shock (AMICS) patients found higher survival when Impella was placed pre-PCI, compared to when Impella was placed after PCI. The ...
After a 2023 marred by recalls and FDA wrath, Johnson & Johnson subsidiary Abiomed has once again issued a recall connected to its Impella blood pumps. Categorized as Class I, the most recent recall ...
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 ...
The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement.
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