P97-34 FOOD AND DRUG ADMINISTRATION FOR IMMEDIATE RELEASE Sharon Snider: 301-827-6242 September 29, 1997 Consumer Inquiries: 800-532-4440 FDA APPROVES IMPLANTED DEVICE TO CONTROL INCONTINENCE The Food and Drug Administration today approved an implanted nerve stimulator to treat a serious type of urinary incontinence in adults. The device is intended for women and men who have urge incontinence, a sudden uncontrollable loss of urine caused by involuntary bladder wall contractions. Such contractions may result from neurological conditions such as spinal cord injury, stroke, spina bifida or multiple sclerosis, or from other bladder problems. Urge incontinence affects an estimated 5 million adults -- mostly women. "Implanted nerve stimulators can significantly improve the quality of life of people with urge incontinence because they allow them to go out in public with confidence and without fear of embarrassment," said FDA Lead Deputy Commissioner Michael A. Friedman, M.D. The new device, the Sacral Nerve Stimulation System made by Medtronic, Inc., of Spring Lake Park, Minn., requires major surgery and is intended for use when other less invasive treatments such as drugs and diet modification have failed. About 20 percent of people with urge incontinence would be able to benefit from the device. The product consists of a pulse generator about the size of a pacemaker which is implanted in the abdominal wall and a wire lead which is attached to the nerves near the sacrum, the large bone at the bottom of the spine. The generator sends tiny electric impulses via the implanted wire to the sacral nerves, which help control the bladder contractions. The basic technology of the generator and wire lead is almost identical to that used in another Medtronic device approved in July by FDA, a brain implant for patients with uncontrollable tremors. FDA's approval of the incontinence device was based on a review of clinical studies on safety and effectiveness conducted by the manufacturer and on the recommendation of the Gastroenterology and Urology Devices Panel of FDA's Medical Devices Advisory Committee. To determine effectiveness, surgeons implanted the device in 86 patients with urge incontinence at 16 medical centers in North America and Europe. Eighty percent of the patients were women. All patients were screened with a temporary nerve stimulator implanted through the skin prior to receiving the permanent implant. Of those screened, 63 percent responded to the temporary stimulator and were considered extremely likely to benefit from permanent implantation of the device. It was these from permanent implantation of the device. The device significantly reduced or eliminated urinary incontinence in most patients, meaning the need for absorbent pads or diapers was reduced or eliminated. For example, after six months, 47 percent of patients were completely dry, and an additional 28 percent experienced a reduction in the number of leakage episodes by at least 50 percent. Similar results were seen 12 months and 18 months later. Safety was evaluated in 157 implanted patients who had either urge incontinence or other voiding difficulties. In approximately one third of the patients, at least one additional surgery was required because of problems with the device. The most common problem (35% of patients) was long-term pain, most frequently related to the position of the generator on the abdominal wall. Surgery to reposition the generator usually resolved this problem. Another side effect requiring surgery was migration of the implanted lead wire (7%). Infection or inflammation of the skin (6%) was corrected without surgery in most patients. The device is battery operated, and the battery life is 7 to 9 years. When the battery loses power, surgery will be needed to replace it. FDA is requiring Medtronic to do a five-year study of the device after marketing to determine its long term safety and effectiveness. ####