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
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Cardica Submits MicroCutter XCHANGE™ 30 510(k) Application For Marketing Clearance

Stocks in this article: CRDC





REDWOOD CITY, Calif., Aug. 16, 2013 /PRNewswire/ -- Cardica, Inc. (Nasdaq: CRDC) today announced that it filed regulatory documents with the U.S. Food and Drug Administration (FDA) for marketing clearance of the MicroCutter XCHANGE™ 30, a cutting and stapling device designed to be used in multiple open and minimally invasive surgical procedures. The XCHANGE 30 has a cross-sectional area six times smaller than conventional surgical staplers and articulates up to 80 degrees in each direction. The lower profile provides greater access through a 5 mm trocar.

The submission to the FDA includes the results of Cardica's recently completed MicroCutter European Trial (MET1). In the MET1 study, the MicroCutter XCHANGE 30 met the primary endpoint, freedom of MicroCutter-related severe adverse events when compared to historical controls from the medical literature, with only one event in 160 patients enrolled and 423 deployments.

"The filing of our 510(k) application represents the culmination of effort from many key contributors including the employees who worked tirelessly to deliver an innovative device that addresses a surgical need, the leading physicians who tested the XCHANGE 30 and provided invaluable feedback and the patients that underwent surgical procedures facilitated by the device," commented Bernard A. Hausen, M.D., Ph.D., President and Chief Executive Officer of Cardica. "Pending market clearance by the FDA, we look forward to introducing the MicroCutter XCHANGE 30 in the United States, the world's largest surgical stapling market."

About the MicroCutter XCHANGE 30

Cardica's MicroCutter XCHANGE 30 is available in select centers in Europe today. The device has a cross-sectional area six times smaller than conventional staplers, and articulates up to 80 degrees. The device uses reloadable cartridges with a 30-millimeter staple line length. Laparoscopic procedures today are primarily performed through 5- to 10-mm trocars ports. To accommodate conventional stapling technology, however, surgeons are forced to use 12- or 15-mm trocars, which can result in high post-operative pain, port site infection or ventral hernias. These complications can prolong surgical time, delay discharge, and result in unnecessary hospital readmissions. The smaller cross-sectional area, diameter and much higher articulation of the XCHANGE 30 platform are designed to allow easier access through smaller, less-invasive ports, and to enable faster and easier access to vital organs and tissue for key advanced laparoscopic procedures.



1 of 2

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 17,810.06 +91.06 0.51%
S&P 500 2,063.50 +10.75 0.52%
NASDAQ 4,712.97 +11.1030 0.24%

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