Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.
The medtech giant plans to make the products available on the market on Jan. 15 to expand access to sacral neuromodulation (SNM) therapy for European patients, according to a news release.
InterStim Micro is a rechargeable device designed to deliver SNM therapy for the treatment of overactive bladder, fecal incontinence and non-obstructive urinary retention. It is made to be 80% smaller than the already-existing InterStim II neurostimulator and is touted to have a life span of 15 years with its Overdrive battery technology.
The platform is slated to use the SureScan leads, which are designed to allow for full-body 1.5 and 3 Tesla MRI-conditional scans
“We’re excited our most recent technology advances in sacral neuromodulation will allow physicians to treat more patients who need relief from their symptoms,” said Brooke Story, VP & GM of Medtronic’s pelvic health & gastric therapies business.
“We pioneered this therapy 25 years ago in partnership with physicians, and we have the only five-year data for all indications to demonstrate its safety and efficacy,” Story said in a news release. “We know from deep experience that it’s important the therapy accommodates the lifestyle of the patient to produce the best outcome, and our latest innovations will now offer them a lifestyle-friendly choice in Medtronic SNM systems.”
Dr. Philip E.V. Van Kerrebroeck, a urology professor at Maastricht University Medical Center (Maastricht, The Netherlands), described long-term bladder and bowel control as an under-met medical need.
“The new capabilities offered by MRI-conditional InterStim II and InterStim Micro will give patients the ability to choose a system that is compatible with their lifestyle, and they can have an MRI without being explanted,” Van Kerrebroeck said. “I’m excited because it allows me to offer the trusted experience and support of Medtronic to help give my patients their lives back.”
