FDA Clearance Given for MiniArc(R) Precise Single-Incision Sling From American Medical Systems – Treatment for Incontinence in Women As A Minimally Invasive Procedure

The best news here is only requiring one incision versus several and the launch of the MiniArc will start on a limited basis with a full commercial launch by the end of the year. The procedure can be done as an outpatient. The procedure is covered by most insurance carriers. BD

MINNEAPOLIS, June 28 /PRNewswire-FirstCall/ -- American Medical Systems® (AMS) (Nasdaq: AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, today announced the Food and Drug Administration (FDA) has cleared the MiniArc® Precise Single-Incision Sling System, a product for the treatment of female stress urinary incontinence (SUI). MiniArc Precise is the next generation sling in the MiniArc family sling system, the number one selling single-incision sling in the United States.

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. SUI is more common in women than men and is caused by weakening of pelvic floor muscles often tied to tissue and nerve damage resulting from pregnancy, childbirth, radiation, hormone changes or a prior surgery.

MiniArc Precise system is a next-generation sling procedure, which is minimally invasive and requires only one small incision (as opposed to multiple incisions in traditional sling surgeries) mitigating the potential for tissue trauma, resulting in faster recovery. American Medical will soon commence a limited launch of the product followed by a full commercial launch planned in late 2010.