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 ...
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 ...
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 ...
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 ...
Use of a microaxial flow pump (Impella CP) with standard care led to a lower risk for death than standard care alone in patients with ST-elevation myocardial infarction (STEMI)-related cardiogenic ...
DANVERS, Mass., April 04, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart recovery and support technologies, announced today that the Impella 5.5™ heart ...
DANVERS, Mass., April 8, 2024 – A late breaking clinical trial, presented at the American College of Cardiology conference and simultaneously published in the New England Journal of Medicine, confirms ...
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 ...
WASHINGTON, DC—For patients who present with STEMI complicated by cardiogenic shock (STEMI-CS), it’s not news that the long-awaited DanGer Shock trial showed better 180-day survival after Impella CP ...
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 ...