11.05.2006 – 16:06
ETHICON Announces CE Mark Approval of New Device to Treat Female Stress Incontinence
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 invasive approach.
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.
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Christine Gennaro of Ogilvy Public Relations, +1-212-880-5356
Original content of: ETHICON, INC., transmitted by news aktuell