Medtronic has enrolled the first patient in the Evaluation of InterStim Micro System Performance and Safety (Elite ) study of its InterStim Micro system, a rechargeable sacral neurostimulation (SNS) system.
It is the only study of a rechargeable SNS system to include all SNS indications for symptoms of overactive bladder (OAB). This includes urinary urge incontinence (UUI) and urinary frequency (UF), in addition to non-obstructive urinary retention (NOUR) and faecal incontinence (FI) indications.
Additionally, it is the first rechargeable SNS study to consider faecal incontinence, a condition that affects approximately 20 million adults.
The first patient in the trial was implanted with InterStim Micro system by Urology Partners of North Texas (UPNT) founder Keith Xavier.
Dr Xavier said: “Millions of adults in the US 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 socially by their condition.”
Medtronic plans to enrol 160 subjects in the ELITE study, which is scheduled to take place in 40 sites across Europe, Australia, Canada and the US.
The endpoints of the study include patient-reported outcomes, disease-specific quality of life questionnaires, and symptom diaries.
As part of the study, patients will be followed for two years.
Medtronic Restorative Therapies Group 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 faecal 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 faecal incontinence, or from both OAB and FI, and have no other treatment options available to them.”
In August, Medtronic announced the start of the post-market study of the InterStim Micro System for SNM therapy to treat OAB, FI and NOUR.