|
|
| Los Angeles Physician Launches U.S. Clinical Evaluation of Alternative To Drugs or Surgery for Enlarged Prostate |
| AMERICAN MEDICAL SYSTEMS LOGO
American Medical Systems, Inc. logo. (PRNewsFoto)[AG] MINNEAPOLIS, MN USA | |||
Alcohol Injection Procedure, Designed to Simplify Treatment for Millions of
Men, Begins Nationwide Trials
LOS ANGELES, March 20 /PRNewswire/ -- A Los Angeles physician today
announced the initiation of a clinical trial, evaluating a new therapeutic
option for men suffering the urinary discomfort of an enlarged prostate, a
condition known as benign prostatic hyperplasia (BPH).
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
Dr. Leonard Marks, M.D., reported the first treatments with the AMS
ProstaJect(TM) Ethanol Injection System, a minimally-invasive, transurethral
therapy. The new treatment involves use of a slim, precision injection
technique to deliver medical-grade ethanol to ablate (destroy) cells of an
enlarged prostate gland. The procedure is designed to shrink the bulk of the
gland, which surrounds the urethra, thus facilitating the flow of urine and
allowing the bladder to empty more quickly and completely. This alcohol
injection method should be of most interest to men with BPH, who are not
satisfied with drug therapy, and who wish to avoid surgery, according to Dr.
Marks.
The study is sponsored by American Medical Systems, Inc. (Nasdaq: AMMD)
(AMS) Minneapolis, and is being conducted under an investigational new drug
application (IND) which was issued by the U.S. Food and Drug Administration in
January. An AMS spokesperson said ProstaJect investigators would be enrolling
patients at 13 U.S. medical centers across the nation in this first phase of
the clinical evaluations. The results of this study will add to existing
experience using this therapy in Europe and other countries.
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 invasive surgery that
removes some or all of the enlarged prostate gland but may leave men impotent
and/or incontinent.
Dr. Marks, clinical associate professor of urology at UCLA, commented that
the first procedures were uneventful, requiring only a few minutes of
cystoscopy time, and that the patients were able to go home after a few hours.
Dr. Marks practices urology in West Los Angeles and is medical director of
Urological Sciences Research Foundation, a California non-profit organization
based in Culver City.
Douglas W. Kohrs, president and chief executive officer of AMS noted, "The
new therapy holds promise for millions of 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, "While this is the first U.S. clinical study for the
application of ethanol in the prostate gland, the procedure has already
produced excellent results in Europe. 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 cells in the human liver,
esophagus, and colon, this is the first U.S. 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.
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 . Information about Urological Sciences Research
Foundation and the Prostaject study are available online at
http://www.usrf.org
SOURCE American Medical Systems, Inc.
back to topRelated links:
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:
Kimberly Eggen, Public Relations of American
Medical Systems, 952-930-6326, Kim.Eggen@visitams.com
