This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Abiomed Receives FDA 510(k) Clearance For New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows Of 4L/min

DANVERS, Mass., Sept. 10, 2012 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella® device providing peak flows of approximately four liters of blood per minute. 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™.

"The clinical community has been anxiously anticipating the arrival of this new Impella pump. The Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support," said John Lasala M.D., medical director of Washington University School of Medicine in St. Louis. "It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80% of what a healthy heart can pump each minute."   

"We are very pleased to announce the availability of the new Impella CP and we expect this to be a significant tool in helping more patients," said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. "The addition of the Impella CP to the growing Abiomed product portfolio further emphasizes the company's commitment to innovation and our dedication to patients."

This 510(k) clearance designates that the Impella CP has the same indications for use 1 as the Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU) 2. In April 2012, Abiomed received CE Marking approval to market the Impella cVAD in the European Union 3. Abiomed 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. 

Abiomed has three FDA studies (PROTECT I, RECOVER I, PROTECT II) that are now published on Impella, and there are also over 150 peer reviewed publications including real world usage data from the Europe and U.S. Impella registries. Additionally, Impella has been utilized to support over 10,000 U.S. patients, has been incorporated into the medical guidelines and has recently been approved for a dedicated CPT code for physician payment.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,351.38 +293.03 1.82%
S&P 500 1,948.86 +35.01 1.83%
NASDAQ 4,749.9790 +113.8740 2.46%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs