Leading pelvic-health devices provider American Medical Systems (AMMD) has announced encouraging clinical study results for its Elevate Apical and Posterior vaginal prolapse (or pelvic organ prolapse) repairing system. The company has published the results at the 2010 annual meeting of the International Urogynecological Association (IUGA) and International Continence Society (ICS).
The 12-month study, which was conducted at sixteen centers across the U.S., Canada, Belgium and UK demonstrated encouraging safety and efficacy data of the Elevate system. Data shows an efficacy rate of 89.2% for Apical and 91.7% for Posterior, manifesting the procedure’s effectiveness in restoring pelvic anatomy and improving quality of life.
Moreover, the results also establish that 98.4% of the treated patients would recommend the Elevate system to a friend. The procedure appeared to be safe with low morbidity and nominal postoperative pain. The trial results further validate the Elevate system’s potential as a safe and effective treatment for vaginal prolapse.
More than 34 million women globally (roughly 14 million in the U.S.) are affected by vaginal prolapse (hernia into the vaginal wall), which involves defects of the anterior, apical and posterior vaginal wall. The condition is more common in women who have undergone a hysterectomy (surgical removal of the uterus). There are various surgical and non-surgical alternatives to treat vaginal prolapse.
The minimally-invasive Elevate system is an integral part of American Medical’s Women’s Health business which accounted for roughly a third of its fiscal 2009 revenues. It offers a comprehensive transvaginal approach (with no external incision) aimed at reducing tissue trauma.
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 and is ahead of its nearest rivals, Johnson & Johnson (JNJ) and Boston Scientific Corporation (BSX).
American Medical’s Women’s Health business continues to post mid-to-high teen sales growth. This is attributable to higher sales of pelvic floor repair products buoyed by the success of the Elevate systems.
American Medical remains a dominant player in both male and female incontinence markets. However, the company is exposed to a significant reimbursement risk and its European markets are yet to recover from the macroeconomic headwinds. We are currently Neutral on the stock.
The 12-month study, which was conducted at sixteen centers across the U.S., Canada, Belgium and UK demonstrated encouraging safety and efficacy data of the Elevate system. Data shows an efficacy rate of 89.2% for Apical and 91.7% for Posterior, manifesting the procedure’s effectiveness in restoring pelvic anatomy and improving quality of life.
Moreover, the results also establish that 98.4% of the treated patients would recommend the Elevate system to a friend. The procedure appeared to be safe with low morbidity and nominal postoperative pain. The trial results further validate the Elevate system’s potential as a safe and effective treatment for vaginal prolapse.
More than 34 million women globally (roughly 14 million in the U.S.) are affected by vaginal prolapse (hernia into the vaginal wall), which involves defects of the anterior, apical and posterior vaginal wall. The condition is more common in women who have undergone a hysterectomy (surgical removal of the uterus). There are various surgical and non-surgical alternatives to treat vaginal prolapse.
The minimally-invasive Elevate system is an integral part of American Medical’s Women’s Health business which accounted for roughly a third of its fiscal 2009 revenues. It offers a comprehensive transvaginal approach (with no external incision) aimed at reducing tissue trauma.
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 and is ahead of its nearest rivals, Johnson & Johnson (JNJ) and Boston Scientific Corporation (BSX).
American Medical’s Women’s Health business continues to post mid-to-high teen sales growth. This is attributable to higher sales of pelvic floor repair products buoyed by the success of the Elevate systems.
American Medical remains a dominant player in both male and female incontinence markets. However, the company is exposed to a significant reimbursement risk and its European markets are yet to recover from the macroeconomic headwinds. We are currently Neutral on the stock.
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