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 Provides FDA Update And Reports Second Quarter 2012 Results

Kips Bay Medical, Inc. (NASDAQ: KIPS) today provides an FDA update and announces financial results for its second quarter ended June 30, 2012.

FDA Update

As previously announced on July 18, 2012, Kips Bay Medical filed an application for an Investigational Device Exemption (“IDE”) with the U.S. Food & Drug Administration (“FDA”) to include four U.S. sites in the “eMESH I” clinical feasibility study of its innovative eSVS ® Mesh device currently being pursued in Europe. As of the date of this press release, a number of leading cardiac centers in the U.S. have already expressed an interest in participating in the eMESH I study, pending FDA approval of the IDE.

The eSVS Mesh is a highly flexible, kink-resistant tubular prosthesis made of knitted nitinol wire. It fits externally over the saphenous vein and is designed to provide strength and support for maintaining graft patency.

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.

In Europe, Kips Bay Medical continues to work through the ethics committee review and approval process at its selected clinical study sites. Two sites have received ethics committee approval and are in the process of finalizing clinical study agreements.

Kips Bay Medical intends to enroll up to 120 patients in the eMESH I study, with a primary efficacy endpoint of graft patency, or openness, at twelve months. This feasibility trial is designed to provide information required by the FDA to support the approval of an investigational device exemption (“IDE”) for a larger pivotal study. A pivotal study is required to demonstrate clinical safety and efficacy in support of a request for an approval to sell our eSVS Mesh in the U.S.

1 of 4

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
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,933.50 -136.90 -0.76%
S&P 500 2,094.76 -19.73 -0.93%
NASDAQ 4,946.6310 -70.2980 -1.40%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs