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| American Medical Systems Receives FDA Clearance for Coating Designed To Enhance Erectile Dysfunction Devices |
| AMERICAN MEDICAL SYSTEMS LOGO
American Medical Systems, Inc. logo. (PRNewsFoto)[AG] MINNEAPOLIS, MN USA | |||
Erectile Dysfunction Affects 30 Million U.S. Men
MINNEAPOLIS, May 14 /PRNewswire/ --
American Medical Systems (Nasdaq: AMMD)(AMS), has received Premarket
Approval (PMAS) from the U.S. Food and Drug Administration (FDA) for an
enhancement designed to improve the durability of its 700(TM) Series
inflatable penile implants while maintaining excellent functionality. Dr.
Ajay Nehra, a Urologist at Mayo Clinic, Rochester, Minn. implanted the first
Parylene coated device in the nation. AMS has launched the product worldwide.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
The 700 Series includes devices for the treatment of erectile dysfunction,
a medical condition which makes it difficult for men to have sexual
intercourse. In the United States, an estimated 30 million men suffer from
some degree of erectile dysfunction; 5.6 million are severely affected and the
problem is chronic for 2.8 million men. Drugs such as Viagra help many of the
mild to moderate cases, yet the innovative pill does not satisfy nearly
30 percent of patients. Worldwide sales for erectile dysfunction products are
estimated at $1.2 billion annually.
Internal components of the implantable cylinders are now coated with a
micro-thin (60 millionths of an inch) layer of Parylene. In laboratory
testing, Parylene has added millions of cycles in which the device's cylinders
were folded or stretched without detectable wear.
Larry Getlin, vice president, regulatory, medical affairs and quality
systems at AMS said, "We are pleased with the prompt review and approval of
this important product enhancement. Parylene will improve product performance
and increase acceptance among physicians and their patients seeking
restoration of sexual health."
Hans Neisz, AMS vice president for research and development, noted that,
"American Medical Systems' devices have achieved very high patient
satisfaction ratings. This product improvement underscores our commitment to
continually improve our entire product line. We expect this feature will
benefit patients and cost-conscious healthcare systems worldwide."
American Medical Systems developed the first inflatable penile implant in
1973 and now offers a portfolio of such devices addressing various male needs.
More than 200,000 AMS penile prosthesis have been successfully implanted and
their use is widely accepted as one of the most satisfying, effective
long-term treatments for erectile dysfunction.
American Medical Systems, headquartered in Minneapolis, is a medical
technology company dedicated to surgeon-choice urological solutions for male
and female incontinence, erectile dysfunction, and obstructions related to
prostate disease. For additional information on AMS and its products, visit
http://www.visitams.com
SOURCE American Medical Systems, Inc.
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Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 201-369-3467
CONTACT:
Greg Melsen, Chief Financial Officer of
American Medical Systems, 952-933-4666, greg.melsen@visitAMS.com
, or Kimberly Eggen, Public Relations for American Medical
Systems, 952-930-6326, 800-328-3881, kim.eggen@visitams.com
