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

Kips Bay Medical Announces Filing The IDE For A U.S. FDA Study

Kips Bay Medical, Inc. (NASDAQ:KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, announced today that Kips Bay Medical has filed an application for an Investigational Device Exemption (“IDE”) with the U.S. Food & Drug Administration (“FDA”) to include four U.S. sites in its “eMESH I” clinical feasibility study of its eSVS ® Mesh device currently being pursued in Europe.

Kips Bay Medical submitted this IDE application based upon the FDA’s response to its April 2012 Pre-IDE submission in which Kips Bay provided additional information to the FDA on the performance of its eSVS Mesh. The FDA advised Kips Bay Medical that it was allowed to proceed with this filing for an IDE.

As previously announced, Kips Bay Medical has been pursuing a feasibility trial at eight well known cardiac centers throughout Germany, Switzerland, Italy and France. This European trial is a multi-center, prospective, randomized study of external saphenous vein graft support using its eSVS Mesh in coronary artery bypass grafting (“CABG”) surgery and is titled the "eMESH I" study. If Kips Bay Medical receives approval of this application for an IDE, it intends to expand the eMESH I study to include four of the leading heart hospitals in the United States. The FDA has 30 days to respond to an IDE application.

The objective of this study is to demonstrate the initial safety and performance of the Kips Bay Medical eSVS Mesh sufficient to allow the FDA to approve an IDE for a pivotal study. Kips Bay Medical is currently working through the ethics committee review and approval process at a select group of European study sites. Kips Bay Medical intends to enroll up to 120 patients at eight European and four U.S. cardiac centers, with a primary efficacy endpoint of graft patency, or openness, at twelve months after CABG surgery. Hands-on surgical training with the eSVS Mesh for physicians at several study sites in Europe has already commenced.

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 18,009.31 -25.62 -0.14%
S&P 500 2,104.03 +3.63 0.17%
NASDAQ 5,019.7440 +25.1420 0.50%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs