NEWARK, Calif., Feb. 10 /PRNewswire/ -- Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that Aetna, one of the nation's leading health insurers with over 17 million members, is now covering the non-surgical Renessa treatment for stress urinary incontinence (SUI) in non-pregnant women who are either not able or not willing to undergo surgery for their condition.
According to Aetna's updated policy posted on its website, the insurer now "considers transurethral radiofrequency therapy (Renessa procedure) medically necessary for the treatment of stress urinary incontinence" in these women. The policy goes on to state that the coverage decision was based on the published clinical evidence, as well as on a recent positive assessment by the California Technology Assessment Forum (CTAF), the technology review arm of Blue Shield of California and one of the premier medical technology assessment groups in the country. The CTAF assessment determined that Renessa meets all five of its criteria for "safety, effectiveness and improvement in health outcomes" in appropriately selected patients.
"We are very pleased with Aetna's decision, which validates our strategy to work closely with insurers to provide the clinical evidence they require. Aetna's decision will enhance patient access to this safe and effective office-based treatment option," said Debra Reisenthel, Novasys Medical President and Chief Executive Officer.
Female Stress Urinary Incontinence
SUI is the involuntary leakage of urine associated with laughing, coughing, sneezing and recreational activities. The condition is caused by a variety of factors, most commonly childbirth, and often restricts the social, professional, and personal lives of a significant number of women. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness.
The FDA-cleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing the patient's own collagen in the tissue, thereby reducing or eliminating leaks. The Renessa treatment can be performed in the convenience of a physician's office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations. The Renessa treatment offers an option for women who have tried conservative therapies such as Kegel exercises or biofeedback without success, but who cannot have or do not desire an invasive surgical procedure. To date, over 300 urologists, urogynecologists and gynecologists in 40 states have been trained and have performed the Renessa procedure in over 2500 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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