Medtronic secures CE Mark approval for InterStim products

14 January 2020 (Last Updated January 14th, 2020 10:50)

Irish medical device maker Medtronic has received CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

Medtronic secures CE Mark approval for InterStim products
Medtronic provides various medical technologies for the treatment of cardiovascular disease and cardiac arrhythmias. Credit: Medtronic plc.

Irish medical device maker Medtronic has received CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

By providing full-body MRI scan eligible, lifestyle-friendly choices with InterStim Micro or InterStim II neurostimulators, the firm has increased accessibility to sacral neuromodulation (SNM) therapy for European patients.

InterStim Micro is a rechargeable device, which offers sacral neuromodulation therapy for the treatment of overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention.

InterStim Micro is said to be 80% smaller than the already existing recharge-free InterStim II neurostimulator.

The company claims that the offerings will have a life span of 15 years with its Overdrive battery technology.

SureScan leads are available for use in both InterStim Microsystem, as well as in upcoming implants of the existing recharge-free InterStim II. It also supports full-body 1.5 and 3 Tesla MRI-conditional scans.

Medtronic claims that it is the only firm in Europe to provide patients with a choice between rechargeable and recharge-free systems, which are both full-body MRI-conditional.

Medtronic restorative therapies group’s pelvic health and gastric therapies business general manager and vice president Brooke Story said: “We’re excited our most recent technology advances in sacral neuromodulation will allow physicians to treat more patients who need relief from their symptoms.

“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.

“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.”

Recently, Medtronic acquired privately held American firm Stimgenics for an undisclosed amount to boost pain therapies business.

The acquired company developed a novel spinal cord stimulation (SCS) waveform, differential target multiplexed (DTM) to treat patients with chronic pain.