Medtronic has announced it has been implanted the first patient in its evaluation of InterStim Micro system performance and safety (ELITE) study of the InterStim Micro system.
The ELITE study is 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 faecal incontinence.
Keith Xavier (Urology Partners of North Texas [UPNT], Arlington, USA), a founding partner of UPNT, implanted the patient who suffers from overactive bladder.
“Millions of adults in the USA suffer from bladder and bowel disorders,” says 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 socially by their condition.”
ELITE is the first rechargeable SNS study to include faecal incontinence. Nearly 20 million adults have faecal incontinence, and approximately 11.5 million adults suffer from both overactive bladder and faecal incontinence. Separately, more than 37 million adults in the United States suffer from overactive bladder.
For patients suffering from faecal incontinence, there are few treatment options. Sacral neuromodulation is one of the only effective treatment options for these patients, or from both overactive bladder and faecal incontinence.
The ELITE study will enrol 160 patients across 40 sites in the USA (and territories), Europe, Australia, and Canada. Endpoints include patient-reported outcomes, disease-specific quality of life questionnaires, and symptom diaries. Patients will be followed for two years.
“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 faecal incontinence, or from both overactive bladder and faecal incontinence, and have no other treatment options available to them,” comments Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business, which is part of the Restorative Therapies Group at Medtronic.
The InterStim Micro is 50% smaller than other rechargeable SNS devices on the market, making it the world’s smallest. A company press release claims this allows patients to choose how and when they want to charge their device, depending on the patient’s preference or device settings.
InterStim Micro features SureScan MRI technology, which does not require impedance checks prior to an MRI scan, providing more efficiency in patient care.
The InterStim systems have been implanted in more than 325,000 patients and represent the only SNS technology backed by five-year clinical data.