logo
Plus   Neg
Share
Email

Medtronic Announces FDA Submission For InterStim Micro Neurostimulator

Medtronic plc. (MDT) said Monday that it has filed a pre-market approval or PMA supplement with the United States Food and Drug Administration or FDA for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads.

InterStim Micro is a rechargeable, implantable sacral neuromodulation or 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.

In addition, 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.

The submission, pending regulatory approval from the 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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Amity Packing Company Inc. is recalling around 2,020 pounds of raw ground beef products for possible plastic presence, the U.S. Department of Agriculture's Food Safety and Inspection Service stated. The agency said the products may be contaminated with extraneous materials, specifically clear, thin pliable plastic. The recall was initiated after Pre Brands LLC received two consumer complaints. Golden Pearl Trading Corp. is recalling certain ready-to-eat or RTE imported Siluriformes products that were produced without benefit of import inspection, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced. The recall involves around 12,054 pounds of Siluriformes products that were not presented for import re-inspection into the United States. The U.S. Food and Drug Administration has granted accelerated approval to Tazverik for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Epithelioid sarcoma is a rare sub-type of soft...
Follow RTT
>