FDA approves Medtronic devices
13 August 2020
Medtronic has received approval from the US Food and Drug Administration (FDA) for the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of bladder and bowel control conditions.
InterStim Micro is a small rechargeable device designed to deliver sacral neuromodulation (SNM) therapy. It is used for treating overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention.
Additionally, the device features SureScan MRI technology, which eliminates the need for impedance checks before an MRI scan. The InterStim SureScan MRI leads are used with InterStim Micro and recharge-free InterStim II for full-body 1.5 and 3 Tesla MRI-conditional scans.
Medtronic Restorative Therapies Group Pelvic Health and Gastric Therapies business vice-president and general manager 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 are committed to partnering with physicians to bring life-enhancing technologies to patients.”
Approximately 37 million adults in the US suffer from OAB and nearly 18 million Americans have bowel incontinence. It is estimated that almost 45% who suffer from symptoms do not seek treatment, while seven in ten people stop using medications within six months due to intolerable side effects or unsatisfying results. Medtronic said it expects to offer patients and physicians a choice in SNM systems to match their preferences, lifestyle and treatment goals.
Earlier this year, the company obtained CE mark approval for the InterStim portfolio in Europe. In July, Medtronic signed a deal to acquire Medicrea, a French manufacturer of patient-specific, 3D-printed titanium implants.
Published by Verdict Medical Devices on August 4, 2020
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