Sun Sentinel Palm Beach Edition
Sphincter controller close to human trial phase
Most of us don’t have to give much thought to the mechanics of going to the bathroom.
Our bodies tell our brains when we have to go, and our brains tell our bodies when it’s acceptable to do so.
But millions of people with incontinence have to cope numerous times a day with the reality that the brain-to-body messaging they once took for granted will never operate normally again.
In a small office building in Fort Lauderdale, inventor Peter H. Sayet says he’s close to marketing a device that will enable incontinence sufferers to regain control of their urinary functions.
Sayet is president and CEO of Precision Medical Devices Inc., which he founded in 1998. In the past two decades, the company has secured nine patents and spent $5 million raised from about 200 investors through private-placement stock offerings to develop a Bluetooth-operated bionic sphincter controller, which he calls the Flow Control Device.
It’s an implanted valve designed to fit around the urethra of a man or woman. The valve is opened and closed by a cable connected to a battery-operated controller inserted on the patient’s side, under the skin. When it’s time to urinate, the patient — or in the case of an Alzheimer’s sufferer, a caregiver — uses a wireless fob or phone app to tell the controller to open and close the valve. Batteries are recharged wirelessly and must be replaced every five or six years.
Sayet said he first thought of the idea two decades ago, walking through a supermarket and coming upon a large display of adult diapers. “I thought, ‘How many of those are filling up our landfills? There’s got to be a better solution,’” he said.
In development for 20 years, the Flow Control Device has been successfully implanted in two dozen dogs and should be commercially available for dogs by year’s end, Sayet said.
In addition to extending dogs’ lives, the device’s success with canines could pave the way for the U.S. Food and Drug Administration to green-light human trials sometime next year, followed — Sayet and his investors hope — by approval of the device for human patients by 2020.
The surgery to implant the device should last no longer than 35 minutes and requires a single incision below the belt line, Sayet said. Cost of the procedure and device should be no more than $15,000, he said. It’s not yet known whether the device would be covered by health insurance.
Sayet said the device has the potential to help 35 million to 40 million people with urinary incontinence. They include children with hereditary diseases, including spina bifida, a birth defect that occurs when the spine and spinal cord don’t develop properly and can interfere with operation of the nerves that supply the bowel and bladder. Seventy-five percent of patients with spinal cord injuries suffer incontinence, as do paraplegics. Women often develop urinary incontinence because their pelvic nerves and muscles can be damaged during vaginal childbirth.
The device would also be a quantum leap, Sayet said, over the two most commonly implanted