Medtronic bids for FDA approval of OAB/FI neuromodulation device

Medtronic (NYSE:MDT) said today that it filed a pre-market approval supplement with the FDA for its InterStim Micro neurostimulator and its InterStim SureScan MRI leads.

The InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to send electrical impulses to sacral nerves and normalize connections between the brain, bladder and bowel for treating patients with overactive bladders, urinary urge incontinence, unobstructed urinary retention and fecal incontinence.

Medtronic said it plans to use SureScan MRI leads in the InterStim Micro system, as well as in future implants of the recharge-free InterStim II system. The leads are designed to produce full-body 1.5- and 3-Tesla MRI conditioning labeling. They are still pending FDA approval.

The company believes it is on track to achieve FDA approval for the InterStim Micro and SureScan MRI leads in the spring of 2020.

“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,” Medtronic vice president & general manager of pelvic health & gastric therapies Brooke Story said in a news release. “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.”

Last month, Axonics Modulation Technologies (NSDQ:AXNXwon FDA approval for its own rechargeable sacral neuromodulation device designed to treat urinary and bowel dysfunction in adults with a neurostimulator the size of a USB drive that lasts 15 years in the body. The company has also filed for pre-market approval to get its device indicated for overactive bladder and urinary retention.

Shares of MDT were down -0.8% at $107.69 per share in early-morning trading today.

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