Renessa(R) Treatment for Incontinence Now Covered by Blue Shield of California
First Blues Plan to Cover the In-Office Treatment Option for Women
NEWARK, Calif., April 13 /PRNewswire/ -- Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that effective April 2, 2010 Blue Shield of California covers the Renessa® treatment for non-pregnant women diagnosed with moderate to severe stress urinary incontinence (SUI) who are unable or unwilling to undergo surgery.
"We are very pleased that Blue Shield of California has decided to cover the safe and effective non- surgical Renessa treatment in women suffering from the debilitating effects of moderate to severe SUI," said Scott Cramer, Novasys Medical President and Chief Executive Officer. "Other Blues plans across the country are currently considering coverage and many are expected to follow suit," he continued. Blue Shield's coverage policy follows the California Technology Assessment Forum's (CTAF) review of Renessa, which found Renessa meets all five of its criteria for "safety, effectiveness and improvement in health outcomes" in appropriately selected patients. CTAF is one of the preeminent independent medical technology assessment organizations in the country and its reviews are utilized by many payers and providers to evaluate new medical technology.
Female Stress Urinary Incontinence (SUI)
SUI is the involuntary leakage of urine associated with coughing, sneezing, laughing and recreational activities. It is caused by a variety of factors---most commonly childbirth---and often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. alone. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance and/or effectiveness. Experts estimate 80% of women with SUI thus do not seek treatment of any kind.
The FDA-cleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe gently heats the tissue in the bladder neck and upper urethra. The heat denatures the collagen in the tissue, and upon healing, the tissue becomes firmer and more resistant to leaks. The Renessa treatment can be performed in the convenience of a physician's office, or in an outpatient setting, using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations. More than 350 urologists, urogynecologists and gynecologists have been trained and have performed the Renessa procedure in nearly 3,000 patients.
About Novasys Medical
Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women's health. The company's initial focus is the development and commercialization of the Renessa System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI).
For more information, please visit www.novasysmedical.com or call (510) 226-4060.
SOURCE Novasys Medical, Inc.
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