Medtronic has initiated the post-market study of the InterStim Micro System for sacral neuromodulation (SNM) therapy to treat overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention (NOUR).
The Evaluation of InterStim Micro System Performance and Safety (Elite ) study plans to enrol 160 patients.
The prospective, multi-centre, global study, which is designed to confirm the long-term safety, efficacy and patient benefit of SNM therapy with the InterStim Micro System, will be conducted across 40 sites in the US, Europe, Australia and Canada.
The objectives of the ELITE study include patient-reported outcomes, disease-specific quality of life questionnaires and symptom diaries. It aims to follow the patients for a period of two years.
Medtronic Restorative Therapies Pelvic Health and Gastric Therapies business vice-president and general manager Brooke Story said: “By initiating ELITE, Medtronic reinforces its long-standing commitment to SNM therapy.
“In partnership with physicians, we developed SNM therapy more than 25 years ago, and the InterStim system is the gold standard in the industry. Our SNM technology is backed by the only existing five-year clinical data on the market for all SNM indications, and we expect the ELITE study will fortify the established evidence.”
Earlier this month, InterStim Micro neurostimulator received the US Food and Drug Administration (FDA) approval for the treatment of bladder and bowel control conditions. It obtained CE Mark approval in January.
In a separate development, medical technology company Pelvital has obtained the US FDA clearance for its non-invasive, intravaginal home-use device Flyte.
The device is developed to strengthen the muscles of the pelvic floor to help women with stress urinary incontinence (SUI), which affects nearly 16.6 million women in the US.
Pelvital co-founder and CEO Dale Wahlstrom said: “Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbocharges Kegel exercises, the gold standard conservative treatment for SUI.
“Flyte amplifies the treatment impact of Kegels so women see results much sooner – days to weeks instead of months to years.”
The device will be commercially available in the US, starting this month.