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
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

Endologix Announces Presentation Of Data From PEVAR Randomized Trial

IRVINE, Calif., Jan. 28, 2013 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that data from the first prospective, multicenter, randomized clinical trial of a totally percutaneous approach (PEVAR) to endovascular abdominal aortic aneurysm repair (EVAR) was recently presented at two medical meetings. The presentation on the closure device independent substudy was made by Zvonimir Krajcer, MD (Program Director - Peripheral Vascular Interventions, Department of Cardiology, St. Luke's Episcopal Hospital at the Texas Heart Institute, Houston, TX) at the 25 th Annual International Symposium on Endovascular Therapy (ISET), which took place January 19-23, 2013. The presentation on the PEVAR Trial primary analysis was made by Peter R. Nelson, MD, MS (Assistant Professor of Vascular Surgery at University of Florida, Gainesville, FL) at the 37 th Annual Meeting of the Southern Association for Vascular Surgery (SAVS), which took place January 23-26, 2013.

The presentations by Dr. Krajcer and Dr. Nelson reported the randomized trial results comparing PEVAR using the Endologix 21Fr (OD) sheath based system delivered using a percutaneous approach (the 'pre-close' technique) using the Perclose ProGlide® Suture-Mediated Closure System 1, made by healthcare company Abbott, with surgical access EVAR. Key points from the trial include:

  • The primary trial endpoint was met (P<.0036), definitively demonstrating the non-inferiority of PEVAR using the ProGlide closure device to surgical EVAR
  • A 94% procedural technical success rate was achieved in a multicenter setting
  • Mean procedure time was reduced in PEVAR patients by 34 minutes (P=.006). Likewise, mean time to hemostasis was reduced following PEVAR by 13 minutes (P=.002)
  • PEVAR patients required significantly fewer concomitant procedures
  • Favorable trending of PEVAR in several clinical utility outcomes including reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and less analgesics prescribed for groin pain
  • The PEVAR non-inferiority to surgical EVAR persisted through the final 6-month follow-up

The PEVAR Trial was designed to support the safety and effectiveness of the Company's 21Fr and smaller profile EVAR platforms, including the Powerlink ® with IntuiTrak System and the AFX™ Endovascular AAA System in the percutaneous treatment of abdominal aortic aneurysm. The Company anticipates the full data from the presentation made by Dr. Nelson will be published in the Journal of Vascular Surgery during the second quarter 2013.

John McDermott, Chairman, President and Chief Executive Officer of Endologix, said, "The positive results from our PEVAR Trial provide strong clinical evidence supporting a totally percutaneous approach using our integrated sheath-based systems in EVAR procedures. The study demonstrated that PEVAR is non-inferior to surgical EVAR, with significantly reduced procedure times and time to hemostasis. The study also showed positive trends towards lower blood loss, less need for pain medication, and shorter lengths of stay, which are attractive for physicians, hospitals and patients. There was strong interest in the PEVAR data at ISET and SAVS meetings and we remain well positioned, pending FDA approval, to begin training physicians on the PEVAR procedure."

Stock quotes in this article: ELGX 

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.
DOW 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 +2.54 0.14%
NASDAQ 4,095.5160 +9.2910 0.23%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

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