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

Quick Facts

Editors Pick
Bond management titan Bill Gross has filed suit against his former employer, PIMCO, for breach of contract related to his ouster from the company. Gross is looking for damages of at least $200 million for forcing him out of the company, according to court filings. Gross claims that other managers conspired to push him out of the firm he co-founded in order to improve their own finances. Large U.S. companies are holding trillions of dollars overseas in an effort to avoid U.S. taxes, with big-name firms like Apple (AAPL), Pfizer (PFE) and PepsiCo (PEP) named as notable examples. This is the claim made by a pair of non-profit groups, who released a study based on the firms' financial statements. Alcoa Inc. (AA), the largest producer of aluminum in the US, Thursday reported a sharp decline in profit for the third quarter, as sales dropped 11 percent reflecting divestitures and currency headwinds. Both the earnings and revenues fell short of Wall Street analysts' estimates, sending its shares...
comments powered by Disqus
Trade ABMD now with 
Follow RTT