American Medical Systems® (AMS) (NASDAQ: AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, today announced the results of three major clinical studies that each point to a high degree of efficacy and patient satisfaction with AMS’ minimally invasive treatment options for female stress urinary incontinence (SUI) and vaginal prolapse. Alongside these positive outcomes, the studies also revealed that each treatment resulted in minimal post-operative pain for patients and a low incidence of adverse events. The results were first presented at the American Urogynecological Society’s 30th Annual Scientific Meeting held Sept. 24-26 in Hollywood, FL.
“We are pleased to share these results that underscore our commitment to providing clinical data on our treatment solutions for patients with troubling pelvic health issues,” said Anthony Bihl, president and chief executive officer at American Medical Systems. “Based on these results, we hope that physicians and patients alike will feel confident in choosing AMS’ products to restore their pelvic health and their quality of life.”
The multiple-center studies independently evaluated three AMS products – the MiniArc® Single-Incision Sling System for treating female SUI, the Elevate® Prolapse Repair System and the Perigee® Prolapse Repair System.
MiniArc Sling System Delivers 91 Percent Success Rate
In a 6-month prospective evaluation of AMS’ MiniArc Single-Incision Sling System for surgical treatment of female SUI, the device was found to provide a 91 percent success rate at six months post-op using an objective measure of negative cough stress test (CST) among patients with a positive baseline CST.
The study derived at 16 treatment centers in North America and Europe concluded that MiniArc results in minimal estimated blood loss, minimal length of hospital stay and involves short operative times. The most common complications were reported in less than 2% of patients with no reports of bowel, urethral, bladder or major vessel perforations.
“The preliminary results of this study show that the MiniArc is highly effective at restoring urinary continence and quality of life for many women with a minimally-invasive, single-incision approach”, said Dr. Michael Kennelly, principal investigator on the study. “We will continue to assess the long term durability up to 24 months”.
Elevate Prolapse Repair System 94.5 Percent Effective at 6 Months
In the single-arm, prospective, multi-center trial encompassing 139 patients with Stage II or greater prolapse at 16 U.S. and European sites, the Elevate Apical and Posterior total transvaginal prolapse repair system demonstrated efficacy rates of 94.5 percent in posterior treatment and 95.1 percent in apical treatment, with minimal mesh extrusion rate of 5.8% at 6 months.
The study also found that patients implanted with the Elevate total transvaginal prolapse repair system had a very low .3 mean pain score on the Wong-Baker scale at three months post-op, and 97.7 percent of patients felt they had achieved improvement in their prolapse symptoms at six months post-op. These study results were further substantiated in a patient survey, where 93.8 percent of patients in the trial reported feeling moderately, very or extremely satisfied with their results, and 99.2 percent said they would recommend the device and procedure to a friend.
“The Elevate apical and posterior prolapse repair system performed well in the trial. We are very pleased with the anatomic success rate of 95% for both apical and posterior vaginal wall prolapse”, said Dr. James Lukban, principal investigator on the study. “Significant improvement in quality of life was also observed”.
88.5 Percent Success Rate with Perigee Prolapse Repair System
AMS’ Perigee Prolapse Repair System delivered excellent anatomical results in 88.5 percent of cases in a 24-month study of 114 patients implanted with the system in a prospective, single-arm; multi-center trial conducted at 8 U.S. sites. Not only did the study reveal a high anatomic success rate but it also reported a significantly improved quality of life.
AMS' portfolio of female SUI and vaginal prolapse treatment solutions help to restore urinary continence and normal vaginal anatomy through minimally invasive procedures.