Tag:

Impella

Latest Headlines

Latest Headlines

DOJ calls off investigation of Abiomed's Impella marketing

Abiomed escaped the wrath of the U.S. Department of Justice, as the DOJ decided to wrap up an investigation of the company's marketing of its Impella 2.5 heart pump device without taking additional action.

Abiomed gains on strong Impella revenue, with U.S. sales ramp to come after recent FDA approval

Heart support tech company Abiomed beat analyst earnings and revenue estimates as well as raised its fiscal 2016 guidance on its latest earnings call. All of this is ahead of incorporating additional U.S. sales for its Impella 2.5, which was approved for a broader indication by FDA on March 23.

Abiomed gains after FDA finally approves tiny heart pump

Abiomed has gained full FDA approval of the Impella 2.5 heart pump for use during elective and urgent high-risk percutaneous coronary intervention procedures. The approval is a long time coming after a series of regulatory setbacks forced the company to seek a PMA approval after the indication under a 510(k) clearance proved too narrow.

Abiomed shares hit all-time high due to strong demand for its Impella heart pumps

Cardiology player Abiomed hogged the headlines today with its stellar Q3 fiscal year 2015 financials and the announcement of FDA approval of its Impella RP for patients with right ventricular failure.   

Abiomed stock surge could ripen the possibility of acquisition

Cardiac device maker Abiomed surged on The Street over the last month, with eager investors pushing the company's stock price up more than 34% since October. The Massachusetts outfit's continued success growing its heart pump revenue is helping to drive the trend, ripening its desirability as a takeover target.

Abiomed kicks off FDA-targeted trial for new Impella

Now that Abiomed has steered clear of an FDA warning letter over the Impella 2.5 heart pump, the company has launched a PMA-aimed trial of a percutaneous version of the device, enrolling its first of 30 patients.

French devicemaker Carmat SAS readies artificial heart for human trial

French medical device maker Carmat SAS is ready to begin testing its new artificial heart in human patients and awaits final regulatory OK to pull the trigger and get started.

Abiomed gets out from under FDA's Impella warning letter

Abiomed has finally steered cleared the FDA's warning letter over how it marketed its Impella 2.5 heart pump, and now the company can focus on improving sales and getting back in investors' good graces.

FDA wants PMA, not 510(k), for Abiomed's Impella

An FDA panel voted to keep temporary ventricular support devices such as Abiomed's Impella under the Class III device designation, which, under a new set of rules, means they will need to file full PMAs even if they're already cleared.

Abiomed's Impella devices keep pumping with another 510(k) clearance

The Impella heart pump contintues to drive Abiomed's latest success.