Medtronic announced today that it had submitted its new InterStim™ Micro neurostimulator and matching InterStim™ SureScan™ MRI leads for PMA approval by FDA.
According to the press release:
“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.”
It’s not common for companies to announce their submissions – usually one waits for approval – but this may be Medtronic’s way of signaling the market that it’s not far behind Axonics, which received FDA approval for a similar device last month.