Medtronic is reporting this morning the FDA approval of its InterStim® II system, a sacral nerve stimulator, for the treatment of intractable cases of overactive bladder and urinary retention. The system has recently received EU’s CE Mark and in Europe the system 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.”
Company about its device:
More conservative treatments currently available include: behavioral techniques (healthy lifestyle habits, diet modification, biofeedback, bladder retraining, pelvic muscle exercises) and medications (anticholinergics, antispasmodics, antimuscarinics, or tricyclic antidepressants).
InterStim Therapy is a reversible treatment alternative for patients who have found behavioral and pharmacological treatments ineffective or not well tolerated. InterStim Therapy is mild electrical stimulation of a sacral nerve (near the sacrum) via an implantable system that includes a lead, neurostimulator, and an extension.
Other surgical procedures currently available are irreversible. They include: bladder augmentation, bladder denervation, or bladder removal…
The implantable InterStim System uses mild electrical stimulation of the sacral nerve that influences the behavior of the bladder, sphincter, and pelvic floor muscles. In properly selected patients, InterStim Therapy can be dramatically successful in reducing or eliminating symptoms.