Sling for stress incontinence in women receives FDA nod

April 4, 2007

A new, less-invasive treatment for female stress urinary incontinence has garnered clearance from the FDA.

A new, less-invasive treatment for female stress urinary incontinence has garnered clearance from the FDA.

The MiniArc single incision sling system from American Medical Systems Holdings, Inc., Minnetonka, MN, uses a slim needle profile that allows placement of the mesh sling with minimal insertion force and reduced bleeding. Fixation tips secure the sling without need for incisions in the abdomen or groin. Although the system is designed for operating room use, its design may be compatible for application in an office setting.

The company has begun enrolling patients in a clinical evaluation to assess the sling’s safety, efficacy, and physician needs. This evaluation will enable physicians to gauge the effectiveness and user-friendliness of the system prior to widespread distribution.