This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Cardiva Medical, Inc. Announces U.S. FDA Approval For VASCADE™ Vascular Closure System





SUNNYVALE, Calif., Feb. 6, 2013 /PRNewswire/ -- Cardiva Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the VASCADE Vascular Closure System (VCS). Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression, the gold standard for vascular closure for patients undergoing percutaneous procedures through the femoral artery.

"We are thrilled to receive PMA approval for VASCADE," said Charles Maroney, President and CEO. Maroney continued, "We appreciate the effort of our clinical investigators who worked with us to achieve this important milestone and establish a new 3 rdgeneration closure technology.  Cardiva is well positioned to bring this technology to the marketplace to increase patient throughput and provide a safer and more effective alternative to manual compression across the United States."

James Hermiller, M.D. of The Heart Center, Indianapolis, who served as Principal Investigator for the trial said, "I am extremely pleased with the outstanding clinical performance of VASCADE and with the extraordinary contributions by over 65 clinical investigators and their staff at over 20 clinical sites in the U.S and Australia who facilitated the study. With PMA approval, VASCADE will now be available in the U.S. to all physicians who need safe and effective vascular closure."

Frank Zidar, M.D., clinical investigator at The Heart Hospital of Austin commented, "VASCADE is a new generation of extravascular closure technology that offers significant advantages over conventional closure devices and manual compression. I am excited to be able to provide VASCADE to my patients and to integrate it into my practice."

VASCADE, an extravascular closure device, utilizes a unique delivery system based on a proprietary collapsible disc technology that provides temporary hemostasis during the procedure which eliminates the need for an intra-vascular component. Secure and rapid hemostasis is achieved with VASCADE by the deployment of a thrombogenic resorbable collagen patch at the arteriotomy of the femoral artery.

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Try it NOW
Try it NOW
Try it NOW
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 17,678.23 -40.31 -0.23%
S&P 500 2,056.15 -4.90 -0.24%
NASDAQ 4,863.3620 -13.1570 -0.27%

Partners Compare Online Brokers

Free Reports

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