The U.S. FDA has approved the use of Medtronic’s Verify™ Evaluation System for 3-7 day assessment of the potential for long-term restoration of bladder or bowel function before making a long-term treatment commitment.
Background
More than 37 million adults in the United States reportedly suffer from overactive bladder (OAB) and nearly 18 million Americans have bowel incontinence.
Overactive bladder often causes embarrassment and can dramatically affect the quality of daily living, resulting in patients limiting their activities, avoiding social engagements, and restrict their diet.
Among those who do seek treatment for OAB, studies show that 80 percent of patients prescribed oral medications to treat their OAB symptoms stop taking them by 12 months.
Imagine then the benefits of being able to offer a therapy that allows for short term evaluation of its benefits before making a long term commitment. That’s what is promised with the Medtronic Verify™ Evaluation System which allows patients to test the benefits of Medtronic Bladder or Bowel Control Therapy (Sacral Neuromodulation), delivered by the InterStim® System for the chronic symptoms of overactive bladder, non-obstructive urinary retention or bowel incontinence in patients who did not have success with more conservative therapies.
Both the Verify System and the long-term InterStim System provide mild electrical stimulation to the sacral nerves, which are located near the tailbone and help bladder or bowel function. The therapy helps to normalize communication between the bladder or bowel and the brain, and it is clinically proven to eliminate or greatly reduce bladder or bowel control symptoms and significantly improve quality of life. The InterStim System consists of a pacemaker-like device called a neurostimulator and a lead, which are implanted under the skin during a minimally invasive procedure following a successful trial with the Verify System.
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.
Physician comments
“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,” said Steven Siegel, M.D., Director, Metro Urology Centers for Female Urology and Continence Care, Minneapolis, Minnesota. “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.”
Patient comments
“My overactive bladder symptoms ran my life. I quit going places and couldn’t sleep through the night,” said Peggy Smith, who underwent a 4-day trial with the Verify System for Basic Evaluations. “Oral medications didn’t work for me and I was skeptical about trying this. But after this simple trial, I knew the therapy could work.”
After receiving Medtronic Bladder Control Therapy Peggy says she has been pleased with her results. “Now with this therapy I can go places again and not worry about wetting myself,” said Peggy. “It’s a chance to be normal.”
Company comments
“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,” said Linnea Burman, vice president and general manager, gastro/urology therapies at Medtronic. “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.”
Source: Medtronic, plc
published: September 30, 2015 in: Approval/Clearance, Gastroenterology, Medtronic, Urology