business buildings

Medtronic Announces FDA Submission for InterStim™ Micro Neurostimulator and SureScan™ MRI Leads

Medtronic plc (MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States 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 FDA approval. Read more.

Source: Globe Newswire, October 7, 2019

business buildings

InterStim Incontinence and Bladder Control Implant Now Controlled via App

Medtronic won FDA approval to introduce the InterStim smart programmer to control the company’s InterStim neurostimulation system used to manage overactive bladder, bowel incontinence, and some types of urinary retention.  The InterStim system delivers sacral neuromodulation therapy via an implant that looks similar to a cardiac pacemaker.  Read more.

Medgadget, December 17, 2018

tibial nerve

StimGuard Launches Head-to-Head Trial Against Medtronic’s InterStim

StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT).  Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve. Read more.

Source: Massdevice, March 1, 2018