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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Endologix Announces FDA Approval Of First Percutaneous Indication For Endovascular Abdominal Aortic Aneurysm Repair

IRVINE, Calif., April 16, 2013 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval of its premarket approval (PMA) supplement for a broadened indication for the Company's 21Fr profile and smaller EVAR systems to include totally percutaneous endovascular aneurysm repair (PEVAR) based upon the outcomes of the first prospective, multicenter, randomized clinical trial (The PEVAR Trial). The Endologix EVAR platforms include the Powerlink ® with IntuiTrak® System and the AFX™ Endovascular AAA System, which are the first and only among commercially available endografts to achieve the totally percutaneous labeling expansion facilitated using the Perclose ProGlide ® Suture-Mediated Closure System made by healthcare company Abbott. The Company expects to begin training physicians in the U.S. on the PEVAR procedure in the second quarter 2013.

The FDA approval provides the first clinical validation of PEVAR in a multicenter setting using the Company's fully integrated, sheath-based EVAR systems that already had the industry's only contralateral standard percutaneous (9Fr) indication. The trial results, presented at recent medical meetings, found significant benefits following PEVAR compared to surgical vascular access EVAR. PEVAR procedures were completed in 34 minutes less time, required eight times fewer concomitant iliac/femoral artery procedures or repairs, and resulted in achievement of femoral artery hemostasis in 57% less time. Other positive trends favoring PEVAR included reduced blood loss with 72% fewer patients requiring a blood transfusion, 2.5 times fewer patients with a serious adverse event, nearly 50% fewer patients needing analgesics or narcotics for groin pain, and discharge from the hospital 0.5 days earlier.

John McDermott, Chairman, President and Chief Executive Officer of Endologix, said, "We are pleased to receive FDA approval for our PEVAR indication, which provides our sales force with another unique AAA technology to offer our customers. We are now the first and only Company to receive a percutaneous indication for EVAR, which will allow us to begin training physicians on the PEVAR procedure using our unique platform of EVAR systems. We believe physicians and hospitals will be attracted to PEVAR because it is a less invasive procedure that has the potential to significantly reduce procedure times and improve the patient experience. We expect to begin PEVAR training courses in the second quarter, which will lead to a gradual increase in the number of percutaneous cases performed as we progress through the year."

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 17,039.49 +60.36 0.36%
S&P 500 1,992.37 +5.86 0.30%
NASDAQ 4,532.1040 +5.6220 0.12%

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