First Patient Implanted in ELITE Study of InterStim Micro System

ELITE is the Only Study of a Rechargeable Sacral Neurostimulation System to Include All Four Indications, Including Fecal Incontinence, Which Affects Millions

October 6, 2020

Medtronic plc, the global leader in medical technology, today announced the first patient was implanted in its ELITE study of the InterStim Micro system — the only study of a rechargeable sacral neurostimulation (SNS) system to include all SNS indications for symptoms of overactive bladder, including urinary urge incontinence (UUI) and urinary frequency (UF), as well as non-obstructive urinary retention (NOUR) and fecal incontinence (FI). Keith Xavier, M.D., FPMRS, a founding partner of Urology Partners of North Texas (UPNT) implanted the patient, who suffers from overactive bladder.

“Millions of adults in the U.S. suffer from bladder and bowel disorders,” said Dr. Xavier. “Through the ELITE study, our goal is to further validate existing data that sacral neurostimulation is a safe, long-term solution for patients who are limited professionally, personally and socially1 by their condition.”

ELITE is the first rechargeable SNS study to include fecal incontinence, which is significant because nearly 20 million adults have fecal incontinence,2,3 and approximately 11.5 million adults suffer from both OAB and FI.3,4 Separately, more than 37 million adults in the United States suffer from overactive bladder (OAB).5,6 For patients suffering from fecal incontinence, there are few treatment options. Sacral neuromodulation is one of the only effective treatment options for patients suffering from FI, or from both OAB and FI.7

“We designed ELITE to include all four indications, and it’s also the first study of a rechargeable device to include fecal incontinence. This reinforces our 25-year leadership in the SNS market,” said Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business, which is part of the Restorative Therapies Group at Medtronic. “ELITE will provide additional evidence to our existing irrefutable clinical data that InterStim Micro offers patients freedom from conditions that take over their lives, especially for the millions who suffer from fecal incontinence, or from both OAB and FI, and have no other treatment options available to them.”

The Evaluation of InterStim Micro System Performance and Safety (ELITE) study will enroll 160 subjects across 40 sites in the United States (and territories), EuropeAustralia and Canada. Endpoints include patient-reported outcomes, disease-specific quality of life questionnaires, and symptom diaries. Patients will be followed for two years.

The InterStim Micro is 50% smaller than the market’s other rechargeable SNS device, making it the world’s smallest. It allows patients to choose how and when they want to charge their device — from a quick charge once a week, or as infrequent as once per month, depending on the patient’s preference or device settings. InterStim Micro can recharge from zero to 100% in less than an hour*, making it the fastest battery available, and reduces the need for battery replacement surgeries due to its life of 15 years. It features SureScan™ MRI technology, which does not require impedance checks prior to an MRI scan, providing more efficiency in patient care versus the other SNS system on the market. The InterStim systems have been implanted in more than 325,000 patients and represent the only SNS technology backed by 5-year clinical data.

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