|
|
| American Medical Systems Exhibits New Minimally Invasive Sling System At European Association of Urology Annual Meeting |
| AMERICAN MEDICAL SYSTEMS LOGO
American Medical Systems, Inc. logo. (PRNewsFoto)[AG] MINNEAPOLIS, MN USA | |||
SPARC(TM) Sling System Designed to Offer Enhanced Approach to Treating Female
Incontinence
MINNEAPOLIS, April 9 /PRNewswire/ --
American Medical Systems (Nasdaq: AMMD), the leading independent
manufacturer of urological surgical devices, is exhibiting the minimally
invasive SPARC(R) Sling System for the first time at the European Association
of Urology Annual Meeting, April 7-10 in Geneva. The product, in the final
development stages, is designed to offer an enhanced approach over current
treatments for women with stress incontinence. Pending CE Mark approval, AMS
expects a staged roll-out of the product in Europe in the second quarter. In
the United States, the company anticipates making a 510(k) submission to the
Food and Drug Administration in the second quarter to request marketing
clearance.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
"AMS developed the innovative SPARC technique with safety and efficacy in
mind after consultation with surgeons who currently perform sling procedures,"
said Douglas W. Kohrs, AMS president and chief executive officer. "Sling
procedures are the fastest-growing category of stress incontinence treatments.
We are pleased to be at the forefront with another less invasive, potentially
safer treatment option that will increase our market presence."
The SPARC system has been designed to provide a completely new,
potentially safer and simpler option for the placement of slings to support
the female urethra and prevent incontinence. The suprapubic technique employs
thin, curved stainless steel needles advanced through two tiny incisions above
the pubic bone to a vaginal incision below the urethra. A specially designed
sling is then transferred through the needle tunnel. Following correct sling
placement, the sling is adjusted to provide support to the urethra. Most
patients should be able to return home the day of the procedure.
"We believe that by passing the thin needles from above, the risk of
perforating the bowel or damaging blood vessels near the bladder will be
substantially less than with a vaginal approach," said Dr. David Staskin,
Harvard Medical School, Boston. "Using the pubic bone as an anatomical guide
will allow the surgeon to stay within a safety zone. In addition, only one
cystoscopic examination is required to confirm the integrity of the urethra
and bladder."
About Incontinence
Stress incontinence, the involuntary loss of urine while coughing,
sneezing, laughing, lifting or exercise, is the most common type of urinary
incontinence. Worldwide, 23 million people suffer from stress or mixed
incontinence. Most are women and common causes are a weakening of pelvic
floor tissue during pregnancy and childbirth.
The sling procedure, growing at about 30 percent annually, is becoming the
leading technique for treating stress incontinence in women. This outpatient
treatment is suitable for a wide variety of patients and can be performed
using a minimally invasive approach. In a sling procedure, human or synthetic
material is placed beneath the urethra through small incisions and fixated to
support the urethra and prevent leakage.
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
Except for historical information contained herein, the disclosures in
this news release are forward-looking statements made under the Safe Harbor
Provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to certain risks and uncertainties that
could cause actual results to differ materially from those anticipated. These
risks and uncertainties include: continued use of non-invasive treatment
alternatives; continued physician use and endorsement of the company's
products; increased supply of sling material; increasing penetration of the
penile implant market; successful introduction of new products and product
improvements; actions related to reimbursement for the company's products and
potential product recalls. These risks and other relevant risks are described
in more detail in the company's prospectus, dated August 10, 2000, for its
initial public offering of common stock.
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
, 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
