Novasys Medical Launches Latest Generation Renessa®APEX™ System for In-Office Treatment of Stress Incontinence
Enhancements provide more precise energy delivery, improved user control and greater patient comfort.
NEWARK, CALIFORNIA, February 21, 2012 – Novasys Medical, Inc., a developer of innovative therapies in women’s health, announced today that it has launched the newest generation of its Renessa® in-office treatment for stress urinary incontinence in women.
The Renessa treatment is a quick, safe, office-based procedure that has been proven to significantly reduce incontinence episodes and improve patient quality of life without the need for incisions or the implantation of any foreign materials. Renessa has been available for commercial use since FDA clearance in 2005, and the Company’s latest generation System, called RenessaAPEX, builds on a successful, proven track record of safety, effectiveness and durability.
A paper published in December 2011 in the peer-reviewed journal Advances in Urology demonstrated that the Renessa treatment improves symptoms and quality of life in approximately three out of four women. Furthermore, three year results closely matched those at twelve months, proving that the treatment effects are durable. Importantly, the safety of the Renessa treatment has been well-established; there have been no serious adverse events reported.
The Renessa treatment for SUI offers an alternative to surgery for many women. Surgery for SUI often involves the permanent implantation of synthetic mesh. The safety of mesh used in pelvic surgery has recently come under scrutiny by the U.S. Food and Drug Administration (FDA) due to reports of serious complications, including significant, persistent pain, and erosion of the mesh through vaginal tissue [source: [url=http://www.fda.gov/]www.fda.gov ]. “SUI negatively impacts the lives of millions of women, and many are concerned about the risks of surgery,” said Scott Cramer, Novasys Medical President and Chief Executive Officer. “Renessa offers women and their physicians a proven effective, safe treatment option performed in the comfort and convenience of a physician’s office.”
Female Stress Urinary Incontinence (SUI)
SUI is the involuntary leakage of urine associated with coughing, sneezing, laughing and recreational activities. Caused by a variety of factors -- most commonly childbirth -- SUI often restricts the social, professional, and personal lives of an estimated 15 million women in the U.S. With currently available SUI therapies, many patients and physicians have concerns about safety, recovery, compliance and/or effectiveness. Experts estimate 80-90% of women with SUI do not pursue treatment of any kind.
The FDA-cleared Renessa System is an innovative, non-surgical approach to treating SUI in women. The Renessa procedure can be performed in the convenience of a physician’s office using local anesthesia. There are no incisions and no implants or foreign materials are left in the body after the treatment is complete. Recovery is rapid and comfortable, with most patients able to return to normal daily activities the same or the next day.
Women suffering from stress urinary incontinence can learn more about the Renessa treatment by visiting www.Renessa.com. Physicians interested in more details about the procedure can visit www.RenessaMD.com.
About Novasys Medical
Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women’s health. The company’s first product, the Renessa System, is a proprietary, non-surgical approach to the treatment of stress urinary incontinence (SUI) in women.
For more information, please visit www.novasysmedical.com or call (510) 226-4060.
- Contact Information
- Lauri Campbell
- Vice President, Marketing
- Novasys Medical, Inc.
- (1) (510) 226-4060
- Contact via E-mail
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