Medtronic (NYSE:MDT) announced today that it received FDA approval for its InterStim Micro neurostimulator and SureScan MRI leads.
Fridley, Minn.-based Medtronic’s InterStim Micro device for delivering sacral neuromodulation (SNM) therapy is used in treating overactive bladder, fecal incontinence and non-obstructive urinary retention. According to a news release, it is the smallest rechargeable device of its kind.
The new InterStim Micro is 50% smaller than the market’s other rechargeable SNM device, according to the company, and it can recharge from 0% to 100% in less than one hour, holding a battery life of 15 years.
InterStim SureScan MRI leads are used with the InterStim Micro device to allow for full-body 1.5 and 3 Tesla MRI-conditional scans, offering patients and physicians a choice in SNM systems that would match their preferences. Medtronic is making the products available for order immediately, with delivery for patient procedures set to be within days.
“The new InterStim portfolio brings the best choice in SNM therapy, offering MRI conditional recharge and recharge-free options for patients who have tried other therapies with little or no results,” Medtronic president & GM of the pelvic health & gastric therapies business Brooke Story said in the release. “We have the only five-year data for four indications to demonstrate the safety and efficacy of InterStim systems and 25 years’ experience in sacral neuromodulation therapy. We’re committed to partnering with physicians to bring life-enhancing technologies to patients.”