American Medical Systems (AMMD: 22.51 +0.35 +1.58%) has announced that the U.S. Food and Drug Administration (FDA) has approved the company’s MiniArc Precise single-incision sling system for the treatment of female stress urinary incontinence (SUI). MiniArc Precise is the successor to American Medical’s original MiniArc sling system (launched in 2007), the largest selling single-incision sling in the U.S. having been implanted in more than 75,000 patients.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. SUI is triggered by the weakening of pelvic muscles due to previous pelvic surgery (hysterectomy), hormone changes, childbirth, menopause, obesity or damage of nerves/tissues resulting from pregnancy.
Women aged 45 to 54 years mostly suffer from SUI. Currently, there are both surgical and non-surgical treatment (such as weigh loss, exercises, medications and electrical stimulation) options for SUI. At least one-third of the affected patients in the U.S. manifests severe symptoms and requires surgical treatments.
Slings are the most commonly used surgical procedure for SUI. It typically consists of a narrow ribbon-shaped synthetic mesh material or a biomaterial (derived from bovine, porcine or patient’s own tissue) that is placed under the urethra through incisions. The procedure is aimed at replacing the damaged pelvic muscles and providing a point of support under the urethra to lift it back to a normal position and aid urine retention.
MiniArc Precise system is a next-generation sling procedure, which is minimally invasive and requires only one small incision (as opposed to multiple incisions in traditional sling surgeries) mitigating the potential for tissue trauma, resulting in faster recovery. American Medical will soon commence a limited launch of the product followed by a full commercial launch planned in late 2010.
Based in Minnetonka, Minnesota, American Medical is a world leader in manufacturing medical devices and procedures for treating health problems of both men and women including incontinence, benign prostatic hyperplasia (enlargement of the prostate) and menorrhagia (excessive bleeding during menstruation). In addition to U.S., the company sells its products in Canada, Asia, Australia, Europe, and South America.
American Medical has a roughly 35% world market share in female continence products, ahead of its nearest rivals, Johnson & Johnson (JNJ: 59.31 +0.07 +0.12%) and Boston Scientific Corporation (BSX: 5.84 +0.07 +1.21%). Women’s health products contributed roughly 33% to American Medical’s fiscal 2009 revenues. MiniArc Precise represents another significant addition to the company’s female continence product line-up.
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