Medtronic awaits FDA approval on InterStim Micro and SureScan MRI leads

Medtronic has filed for FDA approval of its new, rechargeable sacral neuromodulation implant for the treatment of bowel dysfunction, overactive bladder and urinary incontinence. The submission includes the InterStim Micro device and the SureScan MRI-safe leads, which are compatible with the new device and the non-rechargeable InterStim II system, which could mean new patients receiving that system to undergo previously unindicated full-body scans and other imaging procedures. The InterStim implants send electrical impulses to the sacral nerves located near the base of the spine, to help regulate signals sent between the bowel, bladder and brain. The InterStim Micro is around 80% smaller than the current implant, and has a longer device lifetime of 15 years without requiring battery replacement surgeries. A decision from the FDA is expected in the early part of 2020.
Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business at Medtronic, said: “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. 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.”