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
TheStreet Open House

Boston Scientific Updates PREVAIL Late Breaking Clinical Trials Presentation

Stock quotes in this article: BSX

NATICK, Mass., March 6, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) PREVAIL clinical trial results will be presented in a Late-Breaking Clinical Trial presentation at the 62nd Annual Scientific Sessions of the American College of Cardiology, and will include all three co-primary endpoints that evaluate safety and efficacy of the WATCHMAN® Left Atrial Appendage (LAA) Closure device in patients with nonvalvular atrial fibrillation versus long-term warfarin therapy.  This will be the first time all three co-primary endpoints in the PREVAIL study will be presented.

The preliminary results of the PREVAIL Trial will be presented on March 9 in San Francisco, California by David R. Holmes Jr., M.D., Mayo Clinic, Rochester, Minn., at 9:10 a.m. PT, in the Moscone Center, South, Esplanade Ballroom.

Specifically, Dr. Holmes will present preliminary analysis on the following co-primary endpoints:

  • Acute (7-day) occurrence of death, ischemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention
  • Comparison of composite of stroke, systemic embolism, and cardiovascular/unexplained death at 18 months follow-up
  • Comparison of ischemic stroke or systemic embolism occurring from greater than 7 days post randomization  to 18 months follow-up

"This is truly a late-breaking clinical trial presentation," said Kenneth Stein, M.D., chief medical officer, Cardiac Rhythm Management, Boston Scientific.  "The last patient six-month follow-up occurred in January and the team has been working diligently to complete the preliminary analysis of the data.  The acute procedural results were completed first, and we announced earlier this week that those results would be presented.  We are pleased to announce that the preliminary analysis of the other two endpoints will now be presented as well.  The final fully monitored and adjudicated analysis will be completed in the coming weeks and is expected to be used to support our comprehensive clinical module PMA filing of the WATCHMAN device.  This filing is also expected to include Protect AF four-year outcomes data, the WATCHMAN Pilot study six-year data, the ASAP study and the CAP registry data update." 

The WATCHMAN device was approved for sale in Europe in 2005 and some countries in Asia in 2009.  It is already commercially available in 40 countries worldwide.  In the United States, WATCHMAN is an investigational device, limited by applicable law to investigational use and not available for sale.  Results from the PREVAIL confirmatory study are expected to be submitted for approval by the U.S. Food and Drug Administration (FDA).  The device was developed by Atritech, which Boston Scientific acquired in March 2011.  Please visit http://www.bostonscientific.com/watchman-eu/ for more information.  Images of the WATCHMAN device are available for download at http://bostonscientific.mediaroom.com/image-gallery?mode=gallery&cat=1760.

Both the Mayo Clinic and Dr. Holmes have a financial interest in technology related to this research. 

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!
DOW 17,042.90 -28.32 -0.17%
S&P 500 1,972.29 -5.51 -0.28%
NASDAQ 4,493.39 -12.4620 -0.28%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs