Leading pelvic-health device provider American Medical Systems (AMMD) has announced encouraging clinical trial results for its MiniArc single-incision sling system as a first-line treatment for female stress urinary incontinence (SUI). The company has published the positive data from the trial in the Journal of Urology, the official journal of the American Urological Association (AUA).
 
The 12-month study, which was conducted at sixteen centers across the U.S. , Canada , Belgium and UK , reveals long-term safety, efficacy and patient convenience/tolerance of the MiniArc sling system. Data shows a success rate of 90% for the device in terms of efficacy and its ability to improve a patient’s quality of life by mitigating tissue trauma and offering fast recovery. The trial results further validate MiniArc’s potential as a safe and effective treatment for SUI.  
 
SUI is a common bladder control problem affecting roughly 15 million adult women in the U.S. The condition is characterized by an involuntary loss of urine due to increased abdominal pressure during physical exertion such as coughing, sneezing, laughing and jumping. Slings, which typically consist of a narrow ribbon-shaped synthetic mesh material or a biomaterial, is the most commonly used surgical procedure for SUI.
 
The MiniArc sling system (launched in 2007) is an advanced sling procedure, which is minimally invasive and requires only one small incision as opposed to multiple incisions in traditional sling surgeries. MiniArc is the largest selling single-incision sling in the U.S having been implanted in more than 75,000 patients.
 
American Medical recently received approval of the U.S. Food and Drug Administration (FDA) for its next-generation MiniArc Precise single-incision sling system, a successor to MiniArc, for the treatment of SUI. The company will soon commence a limited launch of the product followed by a full commercial launch planned for late 2010.
 
Minnesota-based American Medical is a world leader in manufacturing medical devices and procedures for treating health problems of both men and women. The company has a roughly 35% world market share in female continence products, ahead of its nearest rivals, Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX).

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