Medical device maker American Medical Systems Holdings Inc. said Monday the Food and Drug Administration has cleared the company to market its treatment for female stress urinary incontinence.
The company said over 33 million women worldwide are affected by SUI, a condition in which activities such as coughing, sneezing, or heavy lifting put pressure on the bladder resulting in unintentional loss of urine.
To treat the condition with the company's new MiniArc Precise Single-Incision Sling System, the physician surgically places a narrow strip of mesh material — called a sling — under the urethra to give it a point of support. The MiniArc Precise is based on the company's original MiniArc sling launched in late 2007.
"With the new design and fixed needle to sling connection, MiniArc Precise further simplifies the ease of use," says John Nealon, senior vice president and general manager of women's health at American Medical Systems. "Its slim needle profile minimizes the potential for tissue trauma and allows for precise placement of the sling under the urethra for support. A limited launch is underway with a full commercial launch later in 2010."
Shares of American Medical Systems Holdings fell a penny to close at $22.74.