HHS NEWS

P97-28                        FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE         Don McLearn: (301) 827-6242

August 18, 1997               

                              Consumer Hotline:(800) 532-4440





           FDA APPROVES NEW HAND IMPLANT FOR QUADRIPLEGICS

                 Approval is a Worldwide First

                                

                                

     The Food and Drug Administration today approved the first

surgically implanted medical device to restore partial hand

movement in certain quadriplegics.  This represents the first

such approval anywhere in the world. 

     The device, the Freehand System made by NeuroControl Corp.

of Cleveland, enables patients to open and close their hand

enough to be able to hold a pen, pour coffee and feed themselves. 

It is the world's first marketed neural prosthetic to restore

function to a paralyzed limb.

     "This device won't help all quadriplegics, but it may help

those who have injury to the lower cervical spinal cord." said

FDA Lead Deputy Commissioner Michael A. Friedman, M.D. "It can

give them enough motor control to grasp, hold and release

objects."

      Freehand system was approved for use in adults who are

quadriplegic as a result of spinal cord injuries that leave them

with some movement in the upper body -- medically categorized as

C5 or C6 injuries.  People with C6 level injuries generally

retain wrist extension while those with C5 level injuries usually 

have essentially no movement of the hand or wrist, but have some 

movement of the elbow and shoulder.  Currently they use external

devices that let them type or operate computers by blowing into a

mouthpiece, or feed themselves with a fork strapped to a hand. 

An estimated 54,000 people in the United States have this type of

spinal cord injury.

     The Freehand system is not approved for use in quadriplegics

who have uncontrolled spasticity, active or recurrent infection,

or who have a pacemaker.

     The new system consists of a pacemaker-size battery and

microprocessor that is implanted into the chest and connected to

electrodes threaded by wire under the skin, down the arm to the

forearm and hand muscles.  The device is controlled by an

externally mounted joy stick-like device on the opposite shoulder

which responds to movements of that shoulder by the patient.  The

motion sends an electronic signal to the implant to tell the

thumb and finger to pinch together to grasp the object.    

Patients will require extensive training and physical

rehabilitation to learn to use the device effectively.

     FDA's approval was based on clinical studies of safety and

effectiveness conducted by the manufacturer and on the

recommendation of the Neurological Devices Panel of FDA's Medical

Devices Advisory Committee.

     The system was implanted in 61 quadriplegics at 15 medical

centers in the United States, Europe and Australia.  Patients had

the device from one month to 11 years, with a median of 1.6

years.  Most received five months rehabilitation and training in

use of the device.  

     Test results showed that finger motion and grasp force

significantly improved for  all patients, enabling them to grasp

and release standard objects such as forks, cans, and VCR tapes. 

Many patients reported improvement in daily living activities and

greater independence with the device.

     Twenty percent of patients required additional surgery for

various reasons related to implantation of the device, including

repositioning the device, replacement of broken electrodes,

removing electrodes because of infection, and repairing damage to

the skin at the site of the incision.

     Side effects included swelling and discomfort (21 percent), 

skin irritation (23 percent), and irritation from incisions or

sutures (16 percent).

     The system may only be implanted by physicians who are

trained and certified in its use.    

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