The MiniArc Single-Incision Sling System (American Medical Systems, Minnetonka, MN) for female stress urinary incontinence offers efficacy rates of 90.6% for negative cough stress test and 84.5% for the 1-hour pad weight test at 12 months, according to a prospective, multicenter study.
The MiniArc Single-Incision Sling System (American Medical Systems, Minnetonka, MN) for female stress urinary incontinence offers efficacy rates of 90.6% for negative cough stress test and 84.5% for the 1-hour pad weight test at 12 months, according to a prospective, multicenter study.
The results of the international trial, conducted at 16 centers in the United States, Canada, Belgium, and the United Kingdom, were published in the Journal of Urology (2010; 184:604-9).
"This study demonstrated that the MiniArc procedure is quick, carries minimal patient morbidity, and is very tolerable, highlighted by short facility stays, minimal post-op discomfort, and a quick return to normal activities," said principal investigator Michael Kennelly, MD, of McKay Urology Research, Charlotte, NC. "This multicenter prospective study shows encouraging results for the MiniArc sling as a first-line treatment for female patients with SUI. Ongoing follow-up through 2 years is planned."
In related news, the FDA has cleared American Medical Systems’ MiniArc Precise system for the treatment of female stress incontinence. The Precise system is a next-generation sling in the MiniArc family sling system.
The MiniArc Precise features a fixed needle-to-sling-tip connection that does not twist or rotate on the needle, potentially preventing mesh twisting during placement. The fixed connection is designed to further simplify the procedure for the surgeon.
The MiniArc Precise’s slim needle profile "minimizes the potential for tissue trauma and allows for precise placement of the sling under the urethra for support," said John Nealon of AMS.
Dr. Kennelly has disclosed financial interest and/or other relationship with AMS, Bard, Allergan, Coloplast, and Hollister.
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