Medtronic received FDA approval for its Verify Evaluation System to be used for basic evaluations of whether sacral nerve neuromodulation therapy will be effective for regaining control of bladder and bowel function. The Verify is in effect a preview of the implantable InterStim neuromodulator, with basic evaluations taking between three and seven days.
The therapy is meant as an option only when other well established methods have failed to work, while trying the Verify doesn’t commit the patient unless it works and the person is satisfied with the results.
The InterStim implant is placed, like a pacemaker, under the skin with an electrical lead going to the sacral nerve. Electrical pulses generated by the device help coordinate the wishes of the brain with the bowel or bladder, helping to control when the patient really has to go.
The Verify System includes a simple, wireless touch-screen controller and a small, concealable external neurostimulator device. It is discreet, easy to use and allows patients to perform many normal daily activities while undergoing the evaluation. There are two types of evaluations: the basic evaluation, initiated through a simple, in-office procedure, uses a temporary lead and lasts 3-7 days; and the advanced evaluation, which is initiated through a minimally invasive outpatient procedure performed in a hospital or surgical center and may last up to 14 days. The trial can be considered a success if a patient experiences a significant reduction in bladder control symptoms, such as going from 14 bathroom visits per day to 7.