NEWARK, Calif., Dec. 7, 2011 /PRNewswire/ -- Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that a clinical trial has proven that the Renessa® treatment for stress urinary incontinence (SUI), a condition that affects 15 million U.S. women, is effective, safe and durable.
Results published in the peer-reviewed journal Advances in Urology in December 2011 demonstrate that at three years post- treatment with Renessa:
- 74% of patients with moderate to severe symptoms had significant improvement in quality of life;
- 71% of all patients experienced improvement in symptoms and quality of life;
- 60% of patients reduced their incontinence episodes by at least half.
The study was presented at the 40th AAGL Global Congress of Minimally Invasive Gynecology in November by investigator and co-author Dr. Harvey A. Winkler, Co-chief of Urogynecology at North Shore-LIJ University in Manhasset, New York. Three year results closely matched those at 12 months, proving that the treatment effects are durable. The study also confirms the safety of the Renessa procedure, as no serious adverse events were reported during the trial or during the three year follow-up period. "This study demonstrates that the Renessa procedure is not only safe and effective in treating the debilitating effects of SUI, but also that symptom and quality of life improvements are durable for at least three years," said Dr. Winkler.
The Renessa treatment for SUI is an alternative to a surgical procedure. Surgery for SUI often involves the permanent implantation of synthetic mesh. Mesh used in SUI 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: www.fda.gov]. "SUI negatively impacts the lives of millions of women, and many are unwilling to accept the risks associated with surgery," said Scott Cramer, Novasys Medical President and Chief Executive Officer. "Renessa provides women and their physicians a proven effective, safe and durable alternative to surgery."
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.
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.
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.
To download a free copy of this paper, visit www.RenessaMD.com/3years.
For more information, please visit www.novasysmedical.com or call (510) 226-4060.
SOURCE Novasys Medical, Inc.