Medtronic's MRI leads and InterStim receive FDA approval

Medtronic has received approval from the FDA for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

InterStim Micro — a small rechargeable device to deliver sacral neuromodulation (SNM) therapy — is used for treating overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention. The InterStim SureScan MRI leads are used with InterStim Micro and with the recharge-free InterStim II, and allow full-body 1.5 and 3 Tesla MRI-conditional scans. 

The two new products mean Medtronic offers patients and physicians a choice in SNM systems to match their preferences, lifestyle and treatment goals. Product is available for order immediately and will be delivered for patient procedures within days.

Dr Steve Siegel, urologist at the Centres for Female Urology and Continence Care at Minnesota Urology, said: “I’m excited about the new InterStim technology because it will allow so many more patients to be able to pursue SNM therapy and get back to living life their way. The new technology by Medtronic allows me and my patients a choice between a rechargeable or a recharge-free system to best suit their lifestyle, and assures them they can have an MRI. Medtronic has left no box unchecked.”

Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business at Medtronic, added: “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.”