Fridley-based Medtronic announced results Monday showing a majority of patients in a research study experienced fewer problems with fecal incontinence and a better quality of life for three years after receiving a new medical device treatment.
The device, called InterStim, was approved in March by the U.S. Food and Drug Administration for the treatment of chronic fecal incontinence. a pacemaker-style device that tries to tame symptoms through electrical stimulation of nerves, InterStim has been approved for more than a decade as a treatment for urinary incontinence in certain patients.
Among the 77 study participants who completed three years of follow-up assessments, 86 percent reported at least a 50 percent reduction in the number of incontinence episodes per week. Complete continence – meaning a 100 percent reduction in episodes – was seen in 40 percent of patients, according to the study being published in a medical journal called Diseases of the Colon & Rectum.
“We estimate that about 2 percent of the population has this problem, and it is a hidden problem,” said Dr. Anders Mellgren, lead author of the study and a professor at the University of Minnesota. “This is something you don’t speak so much about.”
Researchers at the U contributed 27 of the 130 patients included in the new study, which was conducted at 16 research centers. All patients had tried more conservative medical treatments, such as physical therapy, without success, or were not candidates for such treatments.
The InterStim products are part of the company’s division in Fridley for neurology devices, which generated about $1.6 billion in revenue during the company’s most recent fiscal year. Medtronic does not break out revenue figures by product line.
The most common adverse events in the study included pain at the site where the device is implanted in the buttocks as well as numbness. both problems usually resolved themselves with time and with tweaks to the level of stimulation provided by the device, Mellgren said. about 10 percent of patients in the study had an infection.
The device is no bigger than a stopwatch and costs between $10,000 and $15,000, Mellgren estimated. the total cost of an implant is $20,000 to $30,000, according to a Medtronic spokeswoman.
Christopher Snowbeck can be reached at 651-228-5479.