FDA grants AMS clearance for MiniArc Precise Single-Incision Sling System

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.

"We are excited to receive clearance on this important product. It further demonstrates our commitment to product innovation and is a good example of using physician feedback to improve a surgical procedure and support improved outcomes," says John Nealon, senior vice president and general manager of women's health at American Medical Systems.

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.

To treat SUI with the MiniArc Precise system, the physician surgically places a narrow strip of mesh material—called a sling—under the urethra to give it a point of support. This procedure is minimally invasive with only one small incision. MiniArc Precise is built upon the success of the original MiniArc single-incision sling which since its launch in late 2007, has been implanted in more than 75,000 patients and incorporates proven mesh that has been used in more than 750,000 procedures.

"MiniArc Precise builds upon the existing MiniArc Sling. With the new design and fixed needle to sling connection, MiniArc Precise further simplifies the ease of use while maintaining the integrity of the existing MiniArc clinical evidence," says John Nealon. "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."

MiniArc Precise's design incorporates low profile self-fixating tips that provide immediate fixation of the mesh. As an outpatient procedure, the MiniArc Precise generally allows patients to return to normal activities within a few days. The single-incision approach minimizes the potential for tissue trauma, which may provide for enhanced patient recovery.