Medtronic has filed a pre-market approval (PMA) supplement with the FDA for approval of its InterStim Micro neurostimulator and the accompanying InterStim SureScan MRI leads. The device is used to treat 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, reports Medtronic.
“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.”
The rechargeable InterStim Micro device works by sending electrical impulses to the sacral nerves, normalizing 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 FDA approval for the InterStim II system.
If everything goes well, Medtronic would receive 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 United States.
Dublin, Ireland-based Medtronic is one of the world’s largest medical technology, services and solutions companies. The company employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. Medtronic is focused on collaborating with stakeholders around the world to take healthcare Further, Together.