Valley View, Ohio Thousands of people with spinal cord injuries could be freed from dependence on catheters, medications and other adaptive equipment, thanks to a neuroprosthetic device that is designed to restore bladder function.

Cleared in January by the U.S. Food and Drug Administration under the Humanitarian Device Exemption provision, it is manufactured and marketed by NeuroControl Corp. in association with Elyria, Ohio-based Invacare Corp. The provision, which was established by the FDA to speed up the clearance process for products that help a small, underserved population, limits the number of people who could receive the device to 4,000 a year.

"Bladder management is one of the most chronic and devastating complaints of people following spinal cord injury," said Geoff Thrope, vice president of clinical affairs for NeuroControl. "The Vocare Bladder System is liberating for people who are afraid to leave home for fear of a bladder accident or tired of chronic urinary tract infections, living on antibiotics, catheters or leaking."

The system consists of a pacemaker-style stimulator that is surgically implanted under the skin of the abdomen. It sends electrical signals through electrodes to the spinal nerves that lead to the bladder. The signals cause the muscles of the bladder and urethral sphincter to contract, and later relax, allowing the bladder to empty. The user operates the system with an external controller, which can be stored until needed.

So far about 1,500 people worldwide, 29 of whom are in the United States, have been implanted with the device, said Susan Krebs, public relations supervisor for NeuroControl. The company expects that number to grow significantly, based on spinal cord injury statistics. About 10,000 new spinal cord injuries are reported a year, and of those, about 2,500 could qualify for the device, Krebs said. About 73,000 people in the United States could potentially benefit from the system.

What does this mean for home medical equipment providers? They might lose a small portion of their urological and incontinence supply business in the future, but it could take years for the device to reach all of its potential customer base.-M.L.