This Day On The Street
Continue to site right-arrow
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

Manny Villafaña Discusses FDA Update For Kips Bay Medical

Manny Villafaña, Chairman and Chief Executive Officer of Kips Bay Medical (NASDAQ: KIPS), announced that the FDA continues to require additional information from the Company prior to allowing the Company to pursue a clinical study of its eSVS ® MESH in the United States. In its most recent communication, the FDA has advised the Company that, at this time, it does not believe that the Company has provided sufficient data to support the Company’s request for an investigational device exemption (“IDE”) for the eSVS MESH. The FDA also indicated that it will review such additional information when it becomes available.

The Company has been and will continue to diligently pursue additional clinical studies in Europe and the United Arab Emirates (“UAE”) which are intended to generate data on the efficacy of the eSVS MESH to support clinical usage and reimbursement decisions internationally. The Company believes that the results from the European studies will provide the additional data necessary to obtain an IDE from the FDA.

Over the next three months, Kips Bay expects to initiate several post market clinical studies of the eSVS Mesh for use with saphenous vein grafts during coronary artery bypass surgery. These studies will primarily involve several prestigious cardiovascular centers across Europe. These controlled clinical studies will assess short term and long term patency of saphenous vein grafts treated with the eSVS Mesh.

The European studies will include one large prospective, multi-center, randomized, controlled clinical study in 300 patients assessing the short (three to six-month) and long term (two-year) patency of the eSVS Mesh compared to a control graft without an eSVS Mesh; and one prospective, multi-center registry study assessing the short term (six-month) patency of the eSVS Mesh by CT angiography in 100 patients. In the 100 patient registry study, all saphenous vein grafts eligible for the eSVS Mesh will receive a device which will help address the role of the eSVS Mesh during routine coronary artery bypass procedures.

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
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!


DOW 17,712.66 +34.43 0.19%
S&P 500 2,061.02 +4.87 0.24%
NASDAQ 4,891.2190 +27.8570 0.57%

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