There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump's ...

At Apollo Rajshree Hospitals, a 36-year-old man with severe heart failure has been successfully treated using advanced heart support technology. The patient's heart was functioning at only 10% of its ...

Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...

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 ...

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 ...

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 ...

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 ...

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 ...

A new high-tech help for young heart patients has been approved by the U.S. Food and Drug Administration. Doctors say this will allow them to save more lives, an important milestone as we kick off ...

Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death. The issue stems from a manufacturing defect in certain units’ pump driver ...