Medtronic Receives FDA Approval for InterStim II System

Minnesota, MN-based Medtronic, Inc. announced that the FDA has approved the company’s InterStim II system for the treatment of intractable cases of overactive bladder and urinary retention.
    The new system also recently received regulatory approval (CE Mark) in Europe, where InterStim Therapy is indicated for the management of chronic intractable (functional) disorders of the pelvis and lower urinary tract or intestinal tract, including overactive bladder, urinary retention, fecal incontinence, and constipation.
    The InterStim II system adds a new implantable neurostimulator (INS), a new improved patient programmer and upgraded software for the clinician programmer. These advancements offer a choice of neurostimulation devices to accommodate more patients, streamline the implant procedure, and simplify programming and followup care. The improved patient programmer also gives patients more control of their therapy.
    “This new smaller, lighter device combined with the array of smart design changes to other components of the implantable system will make InterStim Therapy more attractive to both physicians and patients,” said Dr. Steven W. Siegel, director of Metropolitan Urologic Specialists’ Center for Continence Care in St. Paul, Minn. “The new patient programmer and physician programmer software upgrade represent a significant step forward for this treatment option for overactive bladder and urinary retention. With all of these enhancements, InterStim Therapy deserves a fresh look from physicians and patients alike.”