Outpatient SUI treatment approved for marketing

September 1, 2005

The FDA has approved for marketing Novasys Medical's Renessa System, a treatment for stress urinary incontinence due to hypermobility in women unresponsive to conservative care who are not candidates for surgical therapy.

The FDA has approved for marketing Novasys Medical's Renessa System, a treatment for stress urinary incontinence due to hypermobility in women unresponsive to conservative care who are not candidates for surgical therapy. The 20-minute outpatient treatment involves applying controlled heat to tissue in the lower urinary tract, denaturing collagen at multiple small sites to increase tissue resistance to involuntary leakage during increased intra-abdominal pressure.

A multicenter clinical trial in 170 women who underwent the Renessa treatment resulted in reduced incontinence episodes, pad use, and leak severity for the majority of study participants, Novasys said.

For more information, visit www.novasysmedical.com.