Devices & Diagnostics

Incontinence device from Medtronic tests well in clinical trials

Medtronic Inc. (NYSE:MDT) got a thumbs up for its InterStim sacral nerve stimulation product’s clinical trials. The Minneapolis, Minn.-based device giant published new data on its InterStim device, showing that it reduced episodes of incontinence and increased quality of life at three years follow-up for a majority of patients. Medtronic, ranked 5th on the MassDevice […]

Medtronic Inc. (NYSE:MDT) got a thumbs up for its InterStim sacral nerve stimulation product’s clinical trials.

The Minneapolis, Minn.-based device giant published new data on its InterStim device, showing that it reduced episodes of incontinence and increased quality of life at three years follow-up for a majority of patients.

Medtronic, ranked 5th on the MassDevice Big 100 list of the world’s largest medical device companies, won expanded FDA clearance for the InterStim minimally invasive bowel control therapy for use in fecal incontinence in April, 2011.

InterStim is an implanted system consisting of a thin wire lead and a neurostimulator. It competes with Uroplasty Inc.’s (NSDQ:UPI) UrgentPC neuromodulation system, so far indicated for urinary incontinence, which does not require implantation and which notched a couple of reimbursement wins last month.

The new study found that 86 percent of the 77 study participants reported a reduction of incontinent episodes by at least half, and the number of episodes per week decreased from a mean of 9.4 to 1.7. Complete continence was reached in 40 percent of the participants.

“Most people can’t begin to fathom the challenges of living with fecal incontinence, and these patients deserve to find effective treatment solutions,” Dr. Anders Mellgren, lead author and clinical professor of surgery at the University of Minnesota, said in prepared remarks. “This large study demonstrates the dramatic long-term impact InterStim Therapy can have on the daily lives of patients dealing with chronic bowel control issues.”

The study, sponsored by Medtronic, was published in the September issue of Diseases of the Colon and Rectum.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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