logo
Share SHARE
FONT-SIZE Plus   Neg

Abiomed Obtains FDA 510(k) Clearance For New Impella Percutaneous Heart Pump

Abiomed Inc. (ABMD), a provider of breakthrough heart support technologies, announced it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute. The company stated that the increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac Power) within the United States and has been commercially known outside the U.S. as the Impella cVAD.

This 510(k) clearance designated that the Impella CP has the same indications for use as the Impella 2.5 and includes a limitation in the Impella CP instructions for use or IFU, the company said.

In April 2012, Abiomed received CE Marking approval to market the Impella cVAD in the European Union.

Abiomed said it plans to have a controlled launch with top heart hospitals in the United States, with full U.S. commercial availability of the Impella CP expected by the fourth quarter of fiscal 2013.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Data storage firm NetApp Inc. (NTAP) Monday said Chief Executive Officer and Chairman Tom Georgens has stepped down. The company has appointed George Kurian, executive vice-president of product operations, as the new CEO. Georgens' resignation comes just couple of weeks after NetApp reported a fourth-quarter... Apparel maker PVH Corp. said Monday after the markets closed that its first quarter profit rose sharply from last year, when results were weighed down by debt modification and extinguishment costs. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly revenue. Walt Disney said its Chief Financial Officer James Rasulo will step down effective June 30, after five years in that position.
comments powered by Disqus
RELATED NEWS
Trade ABMD now with 
Follow RTT