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

Thoratec Announces FDA Approval To Commence REVIVE-IT Study Utilizing HeartMate II®

PLEASANTON, Calif., Jan. 7, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support (MCS) therapies to save, support and restore failing hearts, today announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilizing the HeartMate II® Left Ventricular Assist System. 

REVIVE-IT ( Randomized Evaluation of VAD Inter VEntion before Inotropic Therapy) is a prospective, randomized, controlled trial designed to compare the use of the HeartMate II LVAD with optimal medical management (OMM) in patients with New York Heart Association (NYHA) Class III heart failure.  This feasibility study is intended to provide initial scientific evidence regarding the potential advantages of MCS therapy in treating earlier-stage, less ill heart failure patients who are currently not indicated for LVAD support.

"IDE approval represents a significant milestone for REVIVE-IT, and we are excited to move forward with this important study, which will allow us to examine the use of LVAD technology earlier in the spectrum of heart failure," said Keith Aaronson, M.D., M.S., medical director of the heart transplant program and Center for Circulatory Support at the University of Michigan Cardiovascular Center (UM-CVC).  Aaronson is serving as a co-principal investigator for REVIVE-IT, along with Francis D. Pagani, M.D., Ph.D., surgical director of the heart transplant program and Center for Circulatory Support at the UM-CVC, to whom the REVIVE-IT IDE was issued, and Robert Kormos, M.D., director of the University of Pittsburgh Medical Center (UPMC) Artificial Heart Program and co-director of the UPMC Heart Transplantation Program.

The REVIVE-IT pilot study is designed to enroll up to 100 patients in NYHA Class III heart failure from leading heart failure programs across the U.S.  Patients will receive either the HeartMate II LVAD or OMM (drug therapy).  The primary endpoint for the study is a composite measure of survival, freedom from disabling stroke, and improvement in functional outcomes, as measured by the six-minute walk test. 

1 of 3

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
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,037.97 -42.17 -0.23%
S&P 500 2,108.92 -8.77 -0.41%
NASDAQ 5,060.2460 -31.8390 -0.63%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs