In Brief: HK Medical Technologies' Autocath 100
This article was originally published in The Gray Sheet
Executive Summary
HK Medical Technologies' Autocath 100: San Antonio firm obtains investigational device approval to begin enrollment of the first 60 patients in a long-term pivotal trial of its self-contained intraurethral bladder control device for treatment of female stress urinary incontinence. The approved protocol calls for treatment over two six-month periods. The silver-coated stainless steel Autocath is inserted by a physician and is anchored internally in the bladder as well as externally by a lower retention ring. Available in Europe since March 1997, the device is activated when an individual applies over a two-to-four second period abdominal pressure; the device closes when urine flow ends...