“ These results further demonstrate that high-risk PCI procedures supported by Impella employing contemporary best practices are safe and effective, providing a treatment option for patients who have ...
According to the World Health Organization, diseases of the circulatory system, including heart disease such as heart attacks, are still among the most common causes of death worldwide. Recovering the ...
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 (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 ...
In the latest observational study to address Impella’s role—this time using a large US claims database—patients who received the percutaneous left ventricular assist device (PVAD) during high-risk PCI ...
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Presented as late-breakers at ACC in New Orleans, two separate randomized trials failed to illustrate Impella's benefits in specific cases of patients with blocked coronary arteries. (iStock / Getty ...
DANVERS, Mass. – Nov. 27, 2023 – Abiomed, part of Johnson & Johnson MedTech[1], announces the first patient in the world has been enrolled in the landmark RECOVER IV randomized controlled trial (RCT).
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 ...
Abiomed has reported eight instances of major bleeding, with three ‘contested’ patient deaths related to a leakage issue with its Impella introducer kits.
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.