Medtronic gets FDA nod for two new InterStim products
Medtronic has secured approval from the US Food and Drug Administration (FDA) for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.
The InterStim Micro is claimed to be the market’s smallest rechargeable device, which offers sacral neuromodulation (SNM) therapy to treat overactive bladder (OAB), fecal incontinence (FI) and non-obstructive urinary retention.
Medtronic’s InterStim SureScan MRI leads are suitable to be used with InterStim Micro and recharge-free InterStim II to facilitate full-body 1.5 and 3 Tesla MRI-conditional scans.
The new InterStim Micro is said to be 50% smaller than the market’s other rechargeable SNM device. It is provided with SureScan MRI technology that does not need impedance checks prior to an MRI scan.
The InterStim Micro allows to minmise battery replacement surgeries
In addition, the device enables to avoid battery replacement surgeries due to its life of 15 years.
Medtronic has also stated that it has witnessed the rapid adoption of the new InterStim portfolio in Europe since securing the CE mark in January this year.
Medtronic restorative therapies group’s pelvic health and gastric therapies business general manager and vice president Brooke Story said: “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.
“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.”
In June this year, Medtronic secured FDA approval for its Percept PC deep brain stimulation (DBS) system, which uses BrainSense technology to chronically capture and record brain signals.