This Day On The Street
Continue to site
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

American Medical Systems Enrolls First Patient In Embrace, A 522 Post Market Surveillance Study For The Elevate™ Anterior And Apical Prolapse System

MINNEAPOLIS, June 9, 2014 /PRNewswire/ -- American Medical Systems Inc. (AMS), an Endo International plc (Nasdaq: ENDP) (TSX: ENL) subsidiary and leading provider of  medical technologies for pelvic health, today announced that the first patient has been enrolled in Embrace™,  AMS's 522 post market surveillance study for the Elevate™ Anterior and Apical Prolapse Repair System.  The FDA has required post market surveillance studies be conducted by all manufacturers for transvaginal mesh products currently on the market, to determine the risks compared to the benefits of this approach to treating prolapse.

Dr. Eric Sokol, Co-Chief, Urogynecology and Pelvic Reconstructive Surgery at Stanford University School of Medicine, is the principal investigator for the Embrace study. The study is designed as a large multi-center cohort-controlled study that compares Elevate Anterior and Apical Prolapse Repair System with a native tissue repair control group. "Pelvic organ prolapse is often complex.  Multiple treatment options are needed to address the exact nature and complexity of the prolapse and there are particular circumstances when the placement of transvaginal mesh may be beneficial and appropriate.  The Embrace study will provide valuable information to clinicians and patients about the role of mesh for the treatment of female pelvic organ prolapse," said Dr. Sokol.

The first patient enrolled in the study was by Dr. Michael Ingber from the Center for Specialized Women's Health, Division of Garden State Urology in New Jersey.  The first patient procedure completed in the study was performed by Dr. Richard Bercik of Yale Gynecological Oncology in New Haven, Conn.

The Embrace Study is one of the largest clinical trials ever performed by American Medical Systems, and the largest to date involving the Elevate Anterior and Apical Prolapse Repair System.

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
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 16,611.14 +138.77 0.84%
S&P 500 1,951.36 +27.54 1.43%
NASDAQ 4,707.7750 +80.6910 1.74%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs