American Medical Systems (AMS), a provider of medical devices and therapies for both male and female pelvic health, has received FDA clearance for the MiniArc Precise Single-Incision Sling System, a product for the treatment of female stress urinary incontinence (SUI).
AMS said that 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. The procedure is minimally invasive with only one small incision.
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 minimises the potential for tissue trauma, which may provide for enhanced patient recovery.
John Nealon, senior vice president and general manager of women’s health at American Medical Systems, said: “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.
“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. Its slim needle profile minimises 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.”