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.
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.
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.
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 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 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.
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.
The Impella heart pump contintues to drive Abiomed's latest success.
Five days after Abiomed ($ABMD) ended its 2012 fiscal year in the black with record revenue, investors apparently responded to rumors of potential reimbursement problems with the company's Impella heart pump by driving its share price down by as much as 7%.
The Danvers, MA device company ended its 2012 fiscal year in the black, with record revenue in hand, thanks in large part to its Impella pumps, which are designed to aid an ailing heart rather than replace it.