Medtronic wins expanded FDA PMA for Verify system

Medtronic (NYSE:MDT) said yesterday it won an expanded FDA premarket approval for its Verify system for testing patients for use with its Interstim bladder or bowel control sacral neuromodulation device during basic evaluations.

The Verify allows patients with overactive bladder, non-obstructive urinary retention or bowel incontinence to test Interstim system for 3-7 days before making a long-term commitment, the Fridley, Minn.-based company said.

“Many patients suffering from OAB have failed multiple treatments and the Verify system for basic evaluations uses new technology to make it easier and faster for patients to assess the potential for effective long-term bladder control. Trying sacral neuromodulation before committing to the therapy allows patients to make a long-term decision with confidence and with an excellent chance to get their lives back,” Dr. Steven Siegel of Minneapolis, Minn.’s Metro Urology Centers for Female Urology and Continence Care said in a press release.

The Verify device is a temporary, belt-worn external neurostimulator with a thin lead implanted during a minimally invasive procedure, Medtronic said. After an evaluation period, it helps physicians decide whether to implant the InterStim device, a pacemaker-like neurotransmitter placed under the skin.

“Medtronic developed the Verify system as part of our commitment to provide meaningful innovations that restore health and advance the treatment of overactive bladder, urinary retention and bowel incontinence. Our goal is to provide long-term benefits to patients and the verify system was designed to deliver clinical value by being easy for patients to use and helping physicians make informed treatment decisions with their patients along the continuum of care,” gastro/urology veep Linnea Burman said in prepared remarks.

Medtronic originally launched the device in the U.S. last October with a 2-week evaluation period indication.

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