July 22, 2013
/PRNewswire/ -- American Medical Systems
(AMS), Inc., an Endo Health Solutions Inc. (Nasdaq: ENDP) subsidiary and leading provider of devices and therapies for male and female pelvic health, today announced the U.S. launch of its MiniArc™ Pro single-incision sling system for the treatment of female stress urinary incontinence (SUI). The MiniArc Pro, the third generation of the MiniArc family, is designed with a new visual feedback system that gives the physicians the ability to objectively measure sling tension in a repeatable way to help find the most accurate placement for their patient.
"Slings are the surgical standard of care in treating women with stress urinary incontinence and a valuable treatment option for many women in the U.S. who suffer from this disruptive condition. However, continence slings I used previously did not provide an objective indicator of sling tension, which is different based on each patient," said
, MD, FACOG, FAAFP, Director, The Female Pelvic Medicine Institute of
, Associate Clinical Professor, Division of Urogynecology and Pelvic Reconstructive Surgery,
Medical College of Virginia
. "With the advancements in the MiniArc Pro system, I'm now able to objectively measure and record the sling tension for each patient."
Bladder leakage, also known as urinary incontinence, is the loss of bladder control or involuntary loss of urine. SUI is the most common type of urinary incontinence, which results in the accidental loss of urine when coughing, laughing, sneezing or during heavy lifting, or simply getting up from a chair.
More than 13 million women in
the United States
suffer from SUI.
"At AMS, we are committed to providing world-class medical devices that improve patients' quality of life," said
, AMS president. "The MiniArc family of single-incision slings is the leading mini-sling therapy line in
the United States
, offering physicians and their patients a minimally-invasive option to treat female stress urinary incontinence. We continue to design products such as the MiniArc Pro system to enhance procedural success and patient outcomes. AMS supports its products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies."
MiniArc sling systems were first introduced in 2007 and have been used by more than 168,000 patients worldwide. The MiniArc Pro sling system was designed based on the AMS MiniArc™ and MiniArc Precise™ sling systems, which have shown to have a success rate of 85 to 94 percent at 12 months across multiple studies, including a prospective, multi-center study.
To evaluate the performance of MiniArc sling systems and other Women's Health products, the company is conducting CAPTURE, a prospective, multi-center, observational long term registry of female patients who are implanted with at least one AMS market approved pelvic health product. CAPTURE is registered with ClinicalTrials.gov.