Somerville, New Jersey (ots/PRNewswire)
ETHICON Women's Health & Urology announced today that it received
CE Mark approval in Europe to market the GYNECARE TVT SECUR(i) System
for female stress urinary incontinence (SUI). This new mid-urethral
sling device maintains many of the key elements that made GYNECARE
TVT the gold standard in SUI surgery, and optimizes safety and
convenience through an innovative design that allows for a less
The GYNECARE TVT SECUR System features a small, compact design
that facilitates a novel approach to incontinence surgery that does
not require exit incisions and can be performed under local
anesthesia. The device uses the same unique PROLENE(i) Polypropylene
Mesh used in over one million GYNECARE TVT patients worldwide, and
has been proven safe and effective with seven years of clinical data.
The GYNECARE TVT family of products combines the use of a mesh
tape with a variation of a traditional operation known as a sling
procedure to correct stress urinary incontinence. The mesh tape is
inserted through the vagina and positioned without tension underneath
the urethra, creating a supportive sling. During movement or
exercise, it supports the urethra, allowing it to maintain its seal
to prevent urine loss.
GYNECARE TVT is not intended for women who are or intend to become
pregnant. Women on anticoagulation therapy are also not candidates.
Female SUI is caused by an improperly functioning urethra or
excessive movement of the bladder neck. Unlike other types of
incontinence, SUI is not a problem of the bladder. Normally, the
urethra -- when properly supported by strong pelvic floor muscles and
healthy connective tissue -- maintains a tight seal to prevent
involuntary loss of urine. When a woman suffers from the most common
form of stress urinary incontinence, however, weakened muscles and
pelvic tissues are unable to adequately support the urethra in its
correct position. As a result, during normal movement as pressure is
exerted on the bladder from the diaphragm, the urethra cannot retain
its seal, permitting urine to escape.
Women with SUI involuntarily lose urine during normal daily
activities and movements, such as laughing, coughing, sneezing and
regular exercise. Common causes of SUI include repetitive straining
of the pelvic muscles, childbirth, and loss of pelvic muscle tone.
Because it is both embarrassing and unpredictable, many women with
SUI avoid active lifestyles, shying away from social situations.
ETHICON has received 510(k) clearance from the U.S. FDA to market
the GYNECARE TVT SECUR System. The product will be commercially
available in the fall.
The family of GYNECARE TVT systems is marketed by ETHICON Women's
Health & Urology, a division of ETHICON, INC., a Johnson & Johnson
company. For more information visit http://www.gynecare.com
(i) Trademark of ETHICON, INC.
Web site: http://www.gynecare.com
ots Originaltext: ETHICON, INC.
Im Internet recherchierbar: http://www.presseportal.ch
Christine Gennaro of Ogilvy Public Relations, +1-212-880-5356