CLEVELAND--(BW HealthWire)--June 23, 1998--NeuroControl Corporation
announced today that it has received notification from the Food and Drug
Administration (FDA) that its VOCARE Bladder System has qualified for
Humanitarian Use Device (HUD) designation for use by people with complete
spinal cord injuries. The HUD designation allows NeuroControl Corporation to
apply for a Humanitarian Device Exemption (HDE) approval by the Food and Drug
Administration (FDA). This designation may enable qualified consumers to
benefit from the breakthrough VOCARE Bladder System sooner. Clinical trials
are currently underway and 26 people have been implanted to date in the
NeuroControl Corporation sponsored study.
The VOCARE Bladder System is an implantable device that may restore
bladder and bowel control to people with complete spinal cord injury.
NeuroControl Corporation is the exclusive worldwide distributor of this
device, which is already well known in Europe as the Finetech Brindley Sacral
Root Stimulator.
"The VOCARE Bladder System enables qualified people to regain control of
one of the most chronic and devastating problems that results from a spinal
cord injury - the loss of bladder and bowel functions," said Geoff Thrope,
vice president of clinical affairs at NeuroControl Corporation. "More than
73,000 people in the United States could potentially benefit from the VOCARE
Bladder System."
The NeuroControl VOCARE Bladder System consists of a pacemaker-type
stimulator that is surgically implanted under the skin of the chest or
abdomen. The device sends electrical signals through electrodes to the spinal
nerves that lead to the bladder and bowel. These signals cause the muscles of
the bladder and urethral sphincter to contract. After the bladder has
contracted in response to the electrical stimulus, the sphincter muscles relax
allowing the bladder to empty.
Externally, the user operates the system with an external controller
about the size of a stereo cassette player. This sends command signals and
power to the implant through the external controller that is used when bladder
and bowel stimulation is needed. The external controller can be stored and
only used as needed.
NeuroControl Corporation, founded in 1993, develops and markets
implantable electrical stimulation systems that restore function to paralyzed
muscles and limbs. With offices in Cleveland, Brussels and Melbourne the
company offers products that treat paralysis resulting from spinal cord injury
and stroke. One such product is the recently FDA Approved NeuroControl
Freehand System, a neuroprosthetic device that restores hand grasp in people
with quadriplegia due to spinal cord injury.
NeuroControl Corporation has substantial clinical experience and
proprietary technology arising from partnerships with leading research
programs around the world. For more information, contact NeuroControl
Corporation toll free, 888-333-4918, or by web site, www.neurocontrol.com.
CONTACT:
NeuroControl Corp.
Susan Krebs, 216/738-1450