Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade ABMD now with 
9/10/2012 7:48 AM ET

Abiomed Inc. (ABMD: Quote), 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.

Click here to receive FREE breaking news email alerts for Abiomed Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter. Stocks moved mostly lower during trading on Wednesday, giving back some ground after trending higher over the past several sessions. Selling pressure was relatively subdued, however, limiting the downside for the markets. The major averages all closed in the red, although the tech-heavy Nasdaq underperformed its counterparts by a wide margin. Russian Foreign Minister Sergei Lavrov warned Wednesday that Moscow would retaliate strongly if its "interests" in Ukraine are attacked. He also criticized the Ukrainian administration for relaunching its so-called anti-terrorist operation in the east of the country a day earlier. Lavrov's remarks came in an interview with Russia Today, which published excerpts of the English-language interview to
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.