Medtronic has filed for FDA approval for its InterStim Micro neurostimulator and the accompanying InterStim SureScan MRI leads. The rechargeable device delivers sacral neuromodulation therapy to treat conditions such as overactive bladder, fecal incontinence, unobstructed urinary retention, and urinary urge incontinence. Along with the InterStim Micro, the new leads allow patients with the implanted system to safely receive MRI scans, given certain precautions.
Sacral stimulation involves modulating signals passed between the brain, bowel, and bladder, improving performance of the underlying muscles. Because the new implant is 80% smaller than the currently available, and recharge-free, InterStim II, the InterStim Micro is more comfortable to wear. It also should function for 15 years without needing replacement surgery.
“The FDA submission for InterStim Micro and SureScan MRI leads is a significant milestone for Medtronic and a leap forward in our 20-year history of leadership in sacral neuromodulation,” in a press release said Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business at Medtronic. “Our ultimate goal is to provide safe and effective treatments to patients affected by bladder and bowel dysfunction, and ensure they have a choice in selecting the most appropriate therapy for their unique situation.”