 |
 |
HI, I received this from another list yesterday and thought that it was quite interesting. While it doen't mention PD, it might lead to some other device that would be of help to PWP Linda cg Ben 69/5 [log in to unmask] >FDA OKs Bladder Device for Injured > > WASHINGTON (AP) _ The first implant to help restore bladder function to >Americans with spinal cord injuries received Food and Drug Administration >approval Tuesday. > A severe consequence of paralyzing spinal cord injuries is loss of bladder >control. Patients become dependent on catheters or other hard-to-use equipment >to void their bladders and may be prone to bladder accidents. They're also >vulnerable to repeated urinary tract infections. > NeuroControl Corp.'s Vocare Bladder System is a pacemaker-style stimulator >surgically implanted under the skin of the abdomen. Electrodes send signals to >the spinal nerves that lead to the bladder, causing it to contract and then >relax. Patients switch on the device with an external controller whenever they >want to empty the bladder. > The FDA approved Vocare under a special provision that speeds new technologies >to patients with rare, hard-to-treat diseases. Under that provision, >NeuroControl had to study just 23 Americans to demonstrate Vocare's benefit. >Six months after the implant, 11 of those patients had enough bladder function >restored that they did not need additional bladder-control help, said FDA's Dr. >Daniel Schultz, who oversees urology devices. Also, patients experienced 78 >percent fewer urinary tract infections. > The FDA decided the device was safe enough to sell based on data from over >1,000 patients in Europe, where it has been sold for several years. > But Vocare does pose some problems: Surgery is risky for spinal cord patients, >half of whom experienced some type surgical complication during the U.S. study. >Also, Vocare side effects may include temporary nerve damage or problems with >bowel function such as constipation, Schultz said. >