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. ####