FDA Approves Smart Programmer for Medtronic Neuromodulation System

FDA approved a smart programmer for Medtronic's InterStim neuromodulation therapy system used for the treatment of overactive bladder, chronic fecal incontinence, and non-obstructive urinary retention.

Medtronic's new smart programmer for the InterStim neuromodulation system provides an app-based platform for implant and long-term therapy management.

Medtronic plc

FDA approved a new smart programmer for Medtronic's InterStim system, which provides sacral neuromodulation therapy for the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention.

The new programmer streamlines multiple devices into a single, intuitive, touchscreen Samsung mobile device and enables clinicians to personalize each patient's care and allows patients to manage their therapy simply and discreetly, Medtronic said.

According to the company, more than 37 million adults in the United States (almost one in six) suffer from OAB and nearly 20 million Americans (about one in 12) have bowel incontinence.

"In addition to simplified programming and ongoing management of InterStim therapy, the smart programmer is discreet, which is meaningful to patients because OAB can greatly impact confidence, intimacy, and activities," said Steven Siegel, MD, Metro Urology Centers for Female Urology and Continence Care in Minneapolis, MN. "It takes courage to seek treatment and many struggle to find long-term relief. My goal is to address OAB symptoms and help restore my patients' quality of life, and I'm pleased to have a tool like the InterStim smart programmer for patients who may benefit from neuromodulation."

Designed to deliver easy, streamlined programming, the smart programmer provides an app-based platform for implant and long-term therapy management. Physicians can instantly check MRI eligibility. The smart programmer also provides physicians with insights and access to a detailed, accurate view of the patient's therapy experience, which may help facilitate constructive patient conversations, Medtronic noted. To help optimize efficacy and tailor treatment based on patient needs, patients are able to adjust their therapy themselves, within clinician-defined limits in seven standard preset programs. The smart programmer also leverages Samsung Knox, Samsung's mobile security platform.

"Medtronic pioneered sacral neuromodulation two decades ago and we continue to innovate to improve the patient and physician experience and make it easier for more patients to find effective relief from both OAB and FI with the InterStim system," said Linnea Burman, vice president and general manager of the pelvic health and gastric therapies business, part of the restorative therapies group at Medtronic. "The advanced technology of the smart programmer paves the way for future digital health solutions, like digital symptom tracking, and should give physicians and patients confidence that relief and restored quality of life are possible."

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