MINNEAPOLIS, May 1 /PRNewswire/ -- American Medical Systems (Nasdaq: AMMD)
today reported receipt of marketing approval by the U.S. Food and Drug
Administration of the company's unique antibiotic surface treatment on the AMS
700 series penile prostheses. The FDA's action is its first approval of an
antibiotic surface treatment for a permanent implantable device.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
The surface treatment, known as InhibiZone(TM), is impregnated through a
patented process into the tissue-contacting surfaces of the prostheses. In
laboratory testing, the device elutes the drugs from the surface when exposed
to a warm, moist environment, providing antibiotic action both on the surface
and in a zone surrounding the treated device. Zones of inhibition have been
demonstrated in laboratory testing and have not been verified in clinical
studies.
"We are pleased by the thorough FDA review and approval of InhibiZone,"
said Doug Kohrs, AMS president and CEO. "Improvement of all AMS products is a
continuing focus of the company's development efforts because we realize that
the patient's peace of mind is an important component of any medical therapy.
Physicians and patients will welcome this medical advancement in device
therapy, which comes at a time when many men who fail pharmaceutical
treatments for erectile dysfunction are exploring other treatments."
About 30 million American men between the ages of 40 and 70 are afflicted
with erectile dysfunction (ED), which makes it difficult or impossible for
them to achieve erections sufficient for sexual intercourse. Almost 3 million
are serious, chronic cases and more than 1.1 million of these men annually are
inadequately served by pharmaceutical therapies for ED and may be candidates
to receive a penile prosthesis.
American Medical Systems developed the first inflatable penile prosthesis
in 1973 and now offers a family of devices addressing various patient needs.
More than 200,000 of the company's prostheses have been successfully implanted
and their use is widely accepted as one of the most effective long-term
treatments for ED.
American Medical Systems (AMS), headquartered in Minneapolis, is a medical
technology company dedicated to surgeon-choice urological solutions for both
male and female incontinence, devices for the diagnosis and treatment of
erectile dysfunction; and obstructions related to prostate disease. The
company markets its products in more than 60 countries worldwide. For more
information about AMS and its products, call 800-328-3881 or visit
http://www.visitAMS.com
SOURCE American Medical Systems
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Related links: http://www.visitams.com
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, 952-930-4666, greg.melsen@visitAMS.com , or Kimberly Eggen, Public Relations, 952-930-6326, 800-328-3881, ext. 6326, kim.eggen@visitams.com , both of American Medical Systems
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