Release date: 2016-03-07
At the beginning of the new year, Endo has ushered in a good news. The mesh device Topas developed by the company for the treatment of fecal incontinence was approved by the FDA Gastroenterology-Urology Equipment Expert Committee with an 8-0 result. This also cleared another obstacle for the product to be finally approved by the FDA. By convention, the general decision of the FDA is consistent with the results of its expert committee.
In a clinical study involving 152 patients, 105 patients had a 50% lower probability of developing fecal incontinence. At 36 months of follow-up, the number of patients with incontinence decreased from 18/day to 5 Name / day. The Topas system is recommended for use as a second-line therapy for patients who have not improved after diet adjustment, medication, and pelvic floor muscle training.
In addition, the Expert Committee is also satisfied with the safety of this product. Although in the three years of follow-up, there were 115 respondents who participated in the follow-up, 50 of the respondents had pelvic pain, and 13 respondents had pelvic organ prolapse or recurrence, but experts from the expert committee believe that This may be device-independent and should be attributed to a decline in the patient's physical condition.
Endo also highlighted in the application materials that the new Topas system does not require a transvaginal incision or a correction to the pelvic floor muscles. This also makes it evade the greatest risks of similar medical devices. The company officially submitted the application in April 2014, and the FDA asked it to provide more data and extend its approval time limit by another year. With the support of the FDA's expert committee, Endo's comeback is a must-have.
The Topas system is part of Endo's Women's Health Division, formerly American Medical Systems. In 2015, Endo sold the male medical device business in American Medical Systems to Boston Scientific for $1.6 billion.
Source: Bio Valley
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