WASHINGTON (AP) - The Food and Drug Administration approved a surgically
implanted electronic hand today to help quadriplegics regain the ability to
hold objects, the first such device approved anywhere in the world. 

The Freehand System by NeuroControl Corp. enables some partially paralyzed
patients to open and close their hand enough to write a letter, feed
themselves, even to paint. 

The implant will help quadriplegics whose spinal cord injury is low enough
that they retain some arm movement. Thus, when the implanted hand helps them,
say, grasp a spoon, they then can lift it to eat. 

``Being able to grasp is very important for activities of daily life,'' said
FDA medical device chief Dr. Bruce Burlington. For all 61 quadriplegics who
tested the implant, ``It's really clear that everybody got somewhat better
and other patients got substantially better.'' 

An estimated 54,000 Americans have the type of paralysis, caused by spinal
cord injury, that would make them eligible for the Freehand. Such
quadriplegics retain some movement of their shoulders and upper arms, but
because their hands are paralyzed they still need much assistance. 

Today, these patients get some help from external devices that let them type
on computers by blowing into a mouthpiece, or feed themselves with a fork
strapped to a hand. Patients also try tendon and muscle transplants to give
them a little more movement. 

The Freehand system is an electronic substitute for the brain's nerve
impulses, which in people with healthy spinal cords tell the hand to move. 

A surgeon implants a two-inch device into the chest, threads electrodes under
the skin down to the patient's best hand and attaches them to hand muscles.
Patients wear under their clothing on the opposite shoulder a small joystick.
When they jerk their shoulder, an electronic signal is sent to the implant to
tell the thumb to move toward the fingers in a pinching motion. 

Tap a button on the chest with the arm, and the device forces the muscles
into a more intricate movement to grasp a larger object like a cup. 

Testing of 61 quadriplegics found they all performed tasks of daily living
significantly better with the implant than without, grasping standard objects
such as forks, cans or VCR tapes. 

Twenty percent of patients required additional surgery to reposition the
device, replace broken electrodes or remove electrodes because of infection.
Other side effects included swelling and skin irritation at the implant site.