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| Medical Advancement From American Medical Systems May Offer Millions of US Men A Promising Alternative to Invasive Prostate Surgery or Drugs for BPH |
| AMERICAN MEDICAL SYSTEMS LOGO
American Medical Systems, Inc. logo. (PRNewsFoto)[AG] MINNEAPOLIS, MN USA | |||
AMS Completes FDA Review: Clinical Evaluation of Minimally Invasive Treatment
Begins for Benign Prostatic Growth (BPH)
MINNEAPOLIS, Jan. 10 /PRNewswire/ --
American Medical Systems (Nasdaq: AMMD), announced today that a major
milestone was achieved in the development of its ProstaJect(TM) Ethanol
Injection System for the treatment of enlarged prostate glands, a condition
known as benign prostatic hyperplasia (BPH). The company's application to the
FDA for an investigational new drug application (IND) is now effective. AMS
officials said ProstaJect investigators would begin enrolling patients at
15 U.S. medical centers early this year in the first phase of clinical
evaluations to evaluate safety and tolerability of ethanol injections into
enlarged prostate glands.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
Most men may not even know they have an enlarged prostate, the gland that
surrounds the urethra. However, they are very much aware of the daily
annoyances caused by the gland's enlarged size, such as: urgency, frequency,
dribbling and repeated nighttime bathroom visits. If left untreated,
complications can be severe and lead to infection and other diseases. The
standard treatments to date have been costly drugs, or a highly invasive
surgery that removes some or all of the enlarged prostate gland but may leave
men impotent and/or incontinent (leaking).
The AMS procedure does not remove the gland. Instead, physicians will use
a slim, specialized injection system to deliver ethanol to ablate (destroy)
the cells in the prostate gland. In European marketing clinical studies, some
urologists have performed the procedure in as little as 20 minutes under local
anesthesia with intravenous sedation.
Douglas W. Kohrs, president and chief executive officer of AMS noted, "The
new therapy holds promise for millions of aging men, as a first-line option
for proactive treatment of BPH. The ProstaJect System will potentially offer a
patient-friendly alternative that is less invasive and less costly than
current BPH treatments."
Kohrs adds, "We are proud at AMS to say that this is the first US clinical
study for the application of ethanol in the prostate gland. The ProstaJect
System is an example of AMS' commitment to lead the urology market in meeting
men's health needs through minimally invasive product innovation." While
ethanol has been injected to ablate (destroy) cells in the human liver,
esophagus, and colon, this will be the first study involving the prostate
gland.
BPH, which is the most common type of benign prostate disease, affects
more than 13 million men in the United States alone. More than half of men in
their 60s, and up to 90 percent of those older, suffer from the condition. AMS
estimates that two million men in the United States are currently undergoing
drug therapy for BPH.
Lawrence W. Getlin, AMS vice president for regulatory, medical affairs and
quality systems, noted that, "During U.S. clinical evaluation, urologists will
use the ProstaJect System to inject 98 percent ethanol into cells of the
enlarged prostate gland which surrounds the urethra. This clinical study is a
major stepping stone for AMS to further evaluate the potential for this
therapy to relieve bothersome symptoms associated with BPH."
American Medical Systems is a leading medical technology company dedicated
to surgeon-choice urological solutions for obstructions related to prostate
disease, male and female incontinence, and erectile dysfunction. For
additional information about AMS or its products, visit
http://www.visitAMS.com
SOURCE American Medical Systems
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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
Company News On-Call:
800-758-5804, ext. 135435
CONTACT:
Greg Melsen, Chief Financial Officer of
American Medical Systems, 952-933-4666, greg.melsen@visitAMS.com
, or Kimberly Eggen of AMS Public Relations, 952-930-6326 or
800-328-3881, ext. 6326, kim.eggen@visitams.com
