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| FDA Clears New American Medical Systems SPARC(TM) Sling System for The Treatment of Female Incontinence |
| AMERICAN MEDICAL SYSTEMS LOGO
American Medical Systems, Inc. logo. (PRNewsFoto)[AG] MINNEAPOLIS, MN USA | |||
MINNEAPOLIS, Aug. 14 /PRNewswire/ --
American Medical Systems (Nasdaq: AMMD) today announced that the U.S. Food
and Drug Administration has cleared the AMS SPARC(TM) Sling System for
commercial marketing in the United States. The innovative system designed to
offer a superior surgical approach to placing a sling for the treatment of
female stress incontinence, is now available to U.S. physicians. Sling
procedures, which support the urethra, currently represent more than
40 percent of the total number of surgical procedures for incontinence.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
"The SPARC system has been designed to provide a new, potentially safer
and simpler option for the placement of a sling," said Doug Kohrs, AMS
president and chief executive officer. "The SPARC system joins a rapidly
growing AMS product line and will provide another innovative option for the
treatment of female incontinence."
David Staskin, M.D., of Harvard Medical School, Boston, Mass., notes that
the system and its suprapubic approach provide unique advantages. "We believe
that with passing of the thin needles from above the pubic bone, rather than
below, the risk of perforating the bowel or damaging blood vessels near the
bladder will be substantially less than with a vaginal approach. Using the
pubic bones as an anatomical guide will allow surgeons to stay within the
safety zone of the retropubic space. In addition, only one cystoscopy is
required to confirm the integrity of the urethra and bladder."
Staskin added, "The technique is minimally invasive and most patients are
able to return home the same day. Surgeons already skilled in the
transvaginal or suprapubic approaches or those interested in alternative
procedures will want to explore this new technique."
The SPARC system 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 polypropylene sling, contained in a
plastic passing sheath, is then passed through the needle tunnel. Following
correct sling placement the sheath is removed. The sling tension can be
further adjusted to provide support to the urethra and the needles are
withdrawn and discarded.
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. Of those, 10 million are women in the U.S. Most are women and
common causes are a weakening of pelvic floor tissue during pregnancy and
childbirth.
The sling procedure 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 or enlarged prostate
disease). 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 Registration Statement on Form S-1 dated
June 26, 2001 and its Annual Report on Form 10-K for the year ended
December 31, 2000.
SOURCE American Medical Systems, Inc.
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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 212-782-2840
CONTACT:
Mary Strom, Global Communications Director of
American Medical Systems, Inc., +1-952-933-4666,
mary.strom@visitams.com , or Marian Briggs, mbriggs@psbpr.com ,
or Nancy Johnson, njohnson@psbpr.com , both of Padilla Speer
Beardsley Inc., +1-612-871-8877, for American Medical Systems,
Inc.
