Medtronic plc tells us it has filed a pre-market approval (PMA) supplement with the U.S. FDA for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads.
Background
Overactive bladder (OAB) is thought to be caused by a miscommunication between the bladder and brain. Gentle stimulation of the sacral nerves, delivered by the InterStim system, so called sacral neuromodulation, is thought to normalize the brain-bladder communication pathway thereby restoring bladder function and alleviating symptoms. A similar theory goes for fecal incontinence (FI). Medtronic’s InterStim system is the only sacral neuromodulation solution proven to demonstrate sustained five-year efficacy and quality of life improvements for both OAB and FI.
Newly submitted to the FDA, Medtronic’s 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 FDA approval.
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.
Medtronic says this submission, pending regulatory approval from the FDA, would position the it 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 United States.
Company comments
“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.”
Source: Globe Newswire
published: October 7, 2019 in: Gastroenterology, Medtronic, News, Regulatory, Technology, Urology