|
|
| American Medical Systems Launches Phase I/II Clinical Trials of AMS ProstaJect (TM) Ethanol Injection System |
| AMERICAN MEDICAL SYSTEMS LOGO
American Medical Systems, Inc. logo. (PRNewsFoto)[AG] MINNEAPOLIS, MN USA | |||
Minimally Invasive Procedure is Potential First-Line Treatment for Enlarged
Prostate Disease
MINNEAPOLIS, March 20 /PRNewswire/ --
American Medical Systems (Nasdaq: AMMD), the leading independent
manufacturer of urological surgical devices, has initiated phase I/II clinical
evaluations of the AMS ProstaJect(TM) Ethanol Injection System, a less
invasive and less costly treatment for enlarged prostate glands, a condition
known as benign prostatic hyperplasia (BPH). ProstaJect clinical
investigators have begun enrolling patients at 13 U.S. medical centers under
an investigational new drug application (IND) from the U.S. Food and Drug
Administration (FDA), which became effective in January. This first phase of
clinical evaluation is designed to evaluate safety and tolerability of the
ProstaJect procedure.
(PHOTO: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
"The ProstaJect Ethanol Injection System holds promise for millions of
men, as a first line option for treatment of BPH," said Douglas W. Kohrs, AMS
president and chief executive officer. "This is the first U.S. clinical study
for the application of ethanol in the prostate gland and it exemplifies our
commitment to leading the urology market through minimally invasive product
innovations. Results from European marketing studies initiated in 2000 give us
great confidence as we begin our clinical trials. The ProstaJect system
already has CE Mark approval and will be launched in European markets in April
2001."
The AMS ProstaJect system is a transurethral therapy that 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. The procedure should be of interest to BPH patients who are
not satisfied with drug therapy and wish to avoid surgery. While ethanol has
been injected to ablate cells in the human liver, esophagus and colon; this is
the first study involving the prostate gland.
About BPH
The prostate is a walnut-size gland that surrounds the urethra. An
enlarged prostate can lead to difficulty urinating, in terms of urgency,
frequency and repeated nighttime bathroom visits that can have a significant
impact on quality of life. If left untreated, complications can be severe and
lead to infection and other diseases. BPH, 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 undergoing drug therapy for BPH.
About AMS
American Medical Systems (AMS), headquartered in Minneapolis, is a medical
technology company with 500 employees worldwide. AMS products include a large
portfolio of devices to treat both male and female incontinence, devices for
the diagnosis and treatment of erectile dysfunction; devices for urethral
obstruction caused by benign prostatic hyperplasia (BPH) (enlarged prostate
disease) and advanced surgical products used in transurethral resection of the
prostate. The company markets its products in more than 60 countries
worldwide. For more information about AMS, visit our Web site at
http://www.visitAMS.com
SOURCE American Medical Systems
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:
Greg Melsen, Chief Financial Officer of
American Medical Systems, 952-933-4666, greg.melsen@visitAMS.com
, or Marian Briggs, mbriggs@psbpr.com , or Nancy A. Johnson,
njohnson@psbpr.com , both of Padilla Speer Beardsley Inc.,
612-871-8877, for American Medical Systems
