Contact: Kimberly Eggen
American Medical Systems
LOS ANGELES PHYSICIAN LAUNCHES
U.S. CLINICAL EVALUATION OF ALTERNATIVE TO DRUGS
OR SURGERY FOR ENLARGED PROSTATE
Alcohol Injection Procedure, Designed to Simplify
Treatment for Millions of Men, Begins Nationwide Trials
Los Angeles, California, March 20, 2001 -- 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
Dr. Leonard Marks, M.D., reported the first treatments
with the AMS ProstaJect™ 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.
(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 U.S. 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
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 (Nasdaq: AMMD) 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.