Public Release: 

FDA Panel Recommends Approving System To Aid Paralyzed

Case Western Reserve University

Contact: Kathleen McDermott, 1-800-368-CWRU, kmm5@po.cwru.edu

CLEVELAND -- Researchers at Case Western Reserve University are one step closer to reaching their goal of helping people paralyzed from spinal cord injuries regain the use of their hands.

An advisory panel to the Food and Drug Administration's Office of Device Evaluation recently recommended that the FDA approve a neural prosthetic system which allows paralyzed people to grasp objects such as a spoon or glass without assistance by electrically stimulating their muscles.

The system could be on the market by early next year. Generally the FDA follows the advisory panel's recommendation.

Approximately 50,000 Americans currently have the kind of spinal cord injury paralysis that could benefit from the neuroprosthesis.

"The technology will give people the ability to grasp with one hand and to be able to use that hand to move and manipulate objects," said Hunter Peckham, CWRU professor of biomedical engineering and orthopaedics, who pioneered the neuroprosthesis.

The system allows patients to be more independent and to perform routine activities like eating, personal grooming, and using the telephone so that they can function more fully in society.

Lifetime expenses for a person with quadriplegia can be more than $1.5 million, according to the Spinal Cord Injury Statistical Center.

Peckham, Michael Keith (professor of orthopaedics), and other CWRU researchers in biomedical engineering, systems engineering, orthopaedics, the Cleveland Veterans Administration Medical Center, and MetroHealth Medical Center have spent 25 years developing the system.

The neuroprosthesis is based on technology known as functional electrical stimulation (FES), which delivers minute levels of electrical current to nerves in paralyzed muscles through electrodes placed on or near them.

The technology makes it possible for individuals to grasp objects by employing a joystick-like sensor placed on the chest that relaxes and tightens the hand as the shoulder moves back and forth.

The Cleveland FES Center -- a consortium that includes CWRU, the Cleveland VA Medical Center, MetroHealth, and the Edison Biotechnology Center -- developed the hand prosthesis. NeuroControl Corporation will market it under the name of the Freehand System.

The device could cost between $40,000 and $50,000, including surgical implantation. Currently 19 hospitals worldwide provide the Freehand system to patients.

Since there is nothing in the neuroprosthesis that wears out, it should last for the patient's lifetime.

Peckham said that the researchers are now studying ways to give paralyzed people finer control of their hands, more control of their upper arms, and different ways to activate movement such as through their wrists.

"We want to be able to provide more functionability for people, and to make the systems easier and more natural to use," said Peckham, director of the FES Center.

The National Institutes of Health, the Department of Veterans Affairs, the FDA Office of Orphan Product Development, and the Paralyzed Veterans of America have supported the research.

-CWRU- --

Toni Ferrante-Searle (amf2@po.cwru.edu) 216-368-4443 voice
Editor, "Campus News," Case Western Reserve University 216-368-3546 fax
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