Medtronic announces it has filed a premarket approval (PMA) supplement with the US Food and Drug Administration (FDA) for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending US FDA approval.
The rechargeable InterStim Micro device works by sending electrical impulses to the sacral nerves, normalising the connections between the brain, bladder and bowel. It is 80% smaller than the current recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years. Additionally, the SureScan full-body conditional MRI leads will enable patients to undergo imaging procedures that were not previously indicated under the current US FDA approval for the InterStim II system.
“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, which is part of the Restorative Therapies Group 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.”
This submission, pending regulatory approval from the US FDA, would position the company to achieve approval for the InterStim Micro system and SureScan MRI leads in the spring of 2020, following a standard 180-day review process. The InterStim Micro system and SureScan MRI leads are not yet available for sale in the USA.