Medtronic submits rechargeable sacral neurostimulation device for FDA approval
Medtronic has submitted for FDA approval a new, rechargeable version of its 20-year-old sacral neuromodulation implant, designed to treat bowel dysfunction, overactive bladder and urinary incontinence.
The filing includes the InterStim Micro device as well as the company’s SureScan MRI-safe leads, which are compatible with the new device as well as the non-rechargeable InterStim II system—potentially allowing new patients receiving that system to undergo previously unindicated full-body scans and other imaging procedures.
Both InterStim implants work by sending 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 about 80% smaller than the current implant, and offers an extended device lifetime of 15 years without the need for battery replacement surgeries.
“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,” said Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business at Medtronic, which estimates that InterStim has helped more than 300,000 patients worldwide during that time.
“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,” Story said in a statement. Following the FDA’s standard review timelines, Medtronic estimates an approval decision in the spring of 2020.
The medtech giant’s rechargeable system follows the FDA’s early September approval of Axonics’ neurostimulation implant. About the size of a USB stick, the former FierceMedTech Fierce 15 winner’s device similarly has a 15-year lifespan and is MRI-compatible, and is charged wirelessly through the skin.
Its approval last month covers the treatment of fecal incontinence, though the company has an additional premarket approval filing currently under FDA review for overactive bladder and urinary retention. Axonics plans to begin shipping the device by the end of the year.