American Medical Systems just announced that they have received FDA clearance for their MiniArc Precise single-incision urethral sling for female stress urinary incontinence.
Female stress urinary incontinence is a condition in which any increase in intra-abdominal pressure (such as laughing, coughing, or running) leads to the involuntary loss of urine. One of the treatments for this condition is the surgical placement of a urethral sling, a device that supports the urethra in place of weakened pelvic floor muscles.
Here’s more from the press release:
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.
Read the press release here…
(Pictured: AMS’s Miniarc)