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AMMD: Positive Clinical Data

October 01, 2009 | Comments: 0
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AMMD | JNJ | BSX
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American Medical Systems Holdings, Inc.
(AMMD - Analyst Report) recently announced positive results from three major clinical studies that demonstrated high efficiency and patient satisfaction with the company’s minimally invasive treatment options for female stress urinary incontinence (SUI) and vaginal prolapse. The results also demonstrated low post-operative pain and a low incidence of adverse events for patients.  

The clinical studies were concentrated on three products – the MiniArc Single-Incision Sling System for treating female SUI, the Elevate Prolapse Repair System and the Perigee Prolapse Repair System. Results for each of these studies are presented here:

  • Six-month prospective evaluation of the MiniArc Single-Incision Sling System – The device delivered 91% success rate with the preliminary results pointing towards minimal estimated blood loss, minimal length of hospital stay and short operative times. American Medical Systems will continue evaluating results for up to twenty-four months.
  • Six-month prospective evaluation of the Elevate Prolapse Repair System – The device demonstrated efficiency of 94.5% in posterior treatment and a 95.1% efficiency in apical treatment. The trial evaluated 139 patients with Stage II or greater prolapse at 16 U.S. and European sites.    
  • Twenty-four month study of the Perigee Prolapse Repair System – The device produced 88.5% success rate in 114 patients implanted with the system. This was a single-arm, prospective study conducted across 8 U.S. sites.
The new positive clinical data will boost sales of these products and eventually cater to the top-line growth. Headquartered in Minnetonka, MN, American Medical Systems is a world leader in medical devices and procedures used to treat erectile dysfunction and other men's and women's health problems.

The company competes with Johnson & Johnson (JNJ - Analyst Report) and Boston Scientific Corporation (BSX - Analyst Report).


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