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 ...

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 ...

A new life-saving technology was used during a heartfelt reunion thanks to the world’s smallest heart pump, Impella, giving patients a second chance at life ...

SALT LAKE CITY, March 11, 2025 /PRNewswire/ — In a transformative recent study, the Second Heart Assist Inc. Whisper™ device, a next-generation percutaneous mechanical circulatory support (pMCS) ...

WASHINGTON, D.C.—Johnson & Johnson MedTech’s Abiomed announced that its compressible, expandable heart pump has cleared a pivotal trial, and it’s now headed for FDA review in the coming months. The ...

PHILADELPHIA (KFSN) -- When a patient has a heart attack, doctors are working against the clock. Often their heart is too weak to pump enough blood. Cardiologists in major U.S. medical centers are ...

The US Food and Drug Administration (FDA)-approved labeling for the Impella 5.0 and Impella LD heart pumps (Abiomed) has been expanded to allow for longer support time in critically ill patients, the ...

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company's investigational device exemption application to start ...

When Thorsten Siess was in graduate school, he came up with the idea for a heart device that's now been used in hundreds of thousands of patients... He invented a successful medical device as a ...

Magenta Medical wants to disrupt the mechanical circulatory support (MCS) market with the Elevate Percutaneous Left Ventricular Assist Device (pLVAD). The Kadima, Israel-based company is developing ...