Anchorless Fixation, Retropubic 'Zone Of Safety' Expected to Encourage Usage
In Treatment of Urinary Incontinence
MINNEAPOLIS, May 22 /PRNewswire/ --
American Medical Systems (AMS) (Nasdaq: AMMD), today announced receipt of
the CE Mark and commercial introduction to the European urology market of the
innovative new SPARC(TM) Sling System, designed to offer a superior approach
for the treatment of female incontinence. The CE (Conformite Europeene) Mark
authorizes marketing in the countries of the European Union.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000710/AMSLOGO )
Responding to the desires and suggestions of urologic and gynecologic
incontinence specialists, the SPARC system has been designed to provide a new,
potentially safer and simpler option for the placement of a sling to support
the female urethra. The 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 is adjusted to provide support to the urethra and the needles
withdrawn and discarded.
Dr. David Staskin, of Harvard Medical School, Boston, Mass., believes that
the system and its suprapubic approach provides unique advantages. "We
believe that with passing of the thin needles from above, 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 bone
as an anatomical guide will allow the surgeon 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.
"SPARC is an innovative technique that has been designed after
consultation with surgeons who currently perform this type of procedure, as
well as surgeons who prefer a suprapubic approach with both safety and
efficacy in mind. SPARC is a procedure that provides an alternative to the
conventional pubovaginal sling as well as transvaginal approaches. It can be
performed efficiently and most patients should be able to return home the same
day. Surgeons already skilled in the transvaginal approach, surgeons
performing a suprapubic approach and those surgeons who are currently
interested in an alternative procedure to those available will be interested
in exploring this new, innovative technique."
More than 10 million U.S. women are among the 23 million people worldwide
who suffer the social and hygienic problems that accompany the involuntary
loss of urine resulting from malfunction in any part of the urinary system. A
common cause is a weakening of tissue surrounding the bladder and urethra
because of pelvic injury during pregnancy or childbirth. A variety of
approaches may be used to place the sling device that supports the urethra and
correct the mispositioning that causes incontinence.
American Medical Systems, Inc., headquartered in Minneapolis, Minn., is a
medical technology company with more than 500 employees worldwide. Founded in
1972, AMS is a leading supplier of medical devices to treat urological
disorders. 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) 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 and its products visit
http://www.visitAMS.com
SOURCE American Medical Systems, Inc.
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Related links: http://www.visitams.com
Photo Notes: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, AMS Chief Financial Officer, 952-933-4666, greg.melsen@visitAMS.com , or Kimberly Eggen, AMS Public Relations, 952-930-6326, kim.eggen@visitams.com
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