DANVERS, Mass.--(BUSINESS WIRE)--The versatility and innovation of Abiomed’s (NASDAQ: ABMD) Impella 5.5 with SmartAssist, a minimally-invasive forward flow heart pump, is leading to continued adoption ...
DANVERS, Mass.--(BUSINESS WIRE)--Regulators in three countries have granted approvals to Impella surgical products, as Abiomed (NASDAQ: ABMD) continues to execute its strategy for sustainable growth ...
Abiomed, Inc.’s ABMD newest heart pump, the Impella 5.5 with SmartAssist, recently received FDA pre-market approval based on its safety and efficacy in the therapy of cardiogenic shock. Notably, the ...
Abiomed has announced a recall of some Impella 5.5 with SmartAssist systems after receiving complaints from customers reporting purge fluid leaking from the purge sidearm of the pump. The Impella 5.5 ...
Abiomed is recalling some of its Impella 5.5 with SmartAssist devices in response to complaints about purge fluid leaking from the purge sidearm of the pump. Today, the US Food and Drug Administration ...
Abiomed has begun a recall of several hundred of its Impella heart pumps after receiving nearly 200 complaints, and the FDA this week gave it a Class I rating, indicating a heightened risk of injury ...
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, ...
The FDA has opened up the use of Johnson & Johnson’s miniaturized heart pumps to certain pediatric patients, including those suffering from acute heart failure and cardiogenic shock. The agency ...
DANVERS, Mass.--(BUSINESS WIRE)-- Abiomed (Nasdaq: ABMD) announces the first patient in the world has been successfully implanted with Impella Bridge-to-Recovery (BTR) as part of the heart pump’s U.S.
The labeling for several mechanical circulatory support devices is under a sweeping class I recall due to the risk of left ventricle perforations, the FDA announced Wednesday. While not subject to a ...
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 ...
Impella 5.5 with SmartAssist is a game-changing technology for patients in Japan and Hong Kong. It is a minimally invasive, forward flow, fully unloading heart pump designed by and for heart surgeons ...