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.