The study will enrol 160 subjects across 40 sites in the US, Europe, Australia and Canada
Medtronic begins ELITE Study of InterStim Micro. (Credit: Medtronic.)
Medtronic has implanted first patients in the ELITE trial of its InterStim Micro system to deliver sacral neuromodulation (SNM) for the treatment of overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention (NOUR).
ELITE (Evaluation of InterStim Micro System Performance and Safety) study is designed to enrol 160 subjects across 40 sites in the US, Europe, Australia and Canada, and follow up the subjects for two years.
Patient reported outcomes, disease specific quality of life questionnaires, and symptom diaries include the primary endpoints of the study.
Urology Partners of North Texas (UPNT) founding partner Keith Xavier has implanted the first patient, who has overactive bladder, with InterStim Micro system in the study, .
Xavier said: “Millions of adults in the U.S. suffer from bladder and bowel disorders. 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.”
InterStim Micro is half the size of other available rechargeable SNS devices
Patients suffering from FI are left with only a few treatment options, of which SNM is an effective treatment option for FI or for both OAB and FI.
The medical device maker claimed that ELITE is the first rechargeable SNS study to include FI, and its InterStim Micro system is 50% smaller than the other rechargeable SNS device available in market.
Also, the device features the fastest battery available, that can recharge from zero to 100% in less than an hour, and reduces the need for battery replacement surgeries, and has life of 15 years.
The InterStim Micro system allows patients to charge the device using a rapid charge once a week, or infrequently charge once in a month, based on their choice or device settings.
The SNM device features SureScan MRI technology that prevents the need for impedance checks before an MRI scan, to offer effective patient care than other SNS systems, said the company.
The company has received the US Food and Drug Administration (FDA) approval for the InterStim Micro in August 2020, and CE mark approval in January 2020, to treat bladder and bowel control conditions.
Medtronic pelvic health and gastric therapies business vice president and general manager Brooke Story said: “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.
“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.”