Medtronic has announced that its recently US Food and Drug Administration (FDA)-approved InterStim Micro neurostimulator for sacral neuromodulation (SNM) therapy is now available in the USA. Cleveland Clinic (Cleveland, USA) performed the first patient implant in the nation with the new device.
The company’s press release explains that sacral neuromodulation sends electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Unlike oral medications that target the muscular component of bladder control, SNM offers control of symptoms through direct modulation of the nerve activity, normalising the communication between the bladder and the brain.
“Effective long-term bladder and bowel control is needed for almost 55 million adults in the USA who often experience regular accidents and/or frequency issues that are associated with overactive bladder (OAB) and faecal incontinence (FI),” said Sandip Vasavada, professor at the Glickman Urological and Kidney Institute and section head Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic. “A new FDA-approved option for these patients is a step forward.”
About InterStim Micro:
- At 2.8 cm3, it is 50% smaller than the market’s other rechargeable SNM device, making it the world’s smallest.
- 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.
- Features SureScan MRI technology, which enables full-body MRI conditional scans.
- Does not require impedance checks prior to an MRI scan, providing more efficiency inpatient care versus the other SNM system on the market.
- Can recharge from zero to 100% in less than an hour, making it the fastest battery available.
- Reduces the need for battery replacement surgeries due to its life of 15 years.
“Patients unfortunately limit their lives socially, professionally and personally due to OAB and FI,” said Howard Goldman, professor and vice chairman of Quality and Patient Safety, Glickman Urological and Kidney Institute, Cleveland Clinic. “With this newly FDA-approved device, we have a new option and can offer more patients sacral neuromodulation therapy and improve their quality of life.”
Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business, comments in the press release: “We created our entire InterStim portfolio in partnership with physicians backed by a 25-year track record of experience in sacral neuromodulation including over 325,000 implanted patients, five-year clinical data and more than 1,000 peer-reviewed articles.”