Fwd: [MS_Community] FDA Approves Stair-Climbing Wheelchair

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Approves Stair-Climbing Wheelchair

The Food and Drug Administration (FDA) today approved a

battery-powered wheelchair that relies on a computerized system of

sensors, gyroscopes and electric motors to allow indoor and outdoor

use on stairs, as well as on level and uneven surfaces.

FDA expedited review of the product, called the INDEPENDENCE iBOT 3000

Mobility System, because it represents a breakthrough technology with

the potential to benefit people with disabilities. An estimated 2

million people in the United States use wheelchairs.

" This wheelchair represents a breakthrough in wheelchair technology, "

said FDA Commissioner Mark B. McClellan, M.D., Ph.D. " It can help

improve the quality of life of many people who use wheelchairs by

enabling them to manage stairs, reach high shelves and hold eye-level

conversations. Its approval is emblematic of FDA's commitment to

help

innovative medical technologies reach patients promptly. "

The user can push a button to command the wheelchair to operate in

several different ways. It can be easily converted from a standard

chair with four wheels contacting the ground to an elevated chair

balanced on only two wheels. This is done when the user wants to reach

high objects or wants to be at eye level for conversation. Four-wheel

drive enables the user to traverse rough terrain, travel over gravel

or sand, go up slopes, and climb 4-inch curbs. For use on stairs,

there are two sets of drive wheels that rotate up and over each other

to climb up or down, one step at a time. Because of its unique

balancing mechanism, the wheelchair remains stable and the seat stays

level during all these maneuvers.

To climb up stairs, the occupant backs up to the first step and holds

onto the stair railing. Then he shifts his weight over the rear

wheels, causing the chair to begin rotation of the front wheels up

over the rear wheels and then down onto the first step. As the user

shifts his weight backward and forward, the chair senses this and

adjusts the wheel position to keep his center of gravity under the

wheels. The chair ascends stairs backward and descends forward (the

user always faces down the stairs).

To reach high shelves or hold eye-level conversations with people who

are standing, the occupant shifts his weight over the back wheels so

that the iBOT lifts one pair of wheels off the ground and balances on

the remaining pair of wheels. The user then presses a button to lift

the seat to a higher position.

People must weigh no more than 250 pounds and must have the use of at

least one arm to operate the chair. They also must have good judgment

skills to discern which obstacles, slopes, and stairs to avoid in

order to prevent serious falls. Users must be capable of some exertion

when climbing stairs in the wheelchair by themselves. However, for

users who cannot tolerate such exertion, there is a feature that

allows someone else to hold onto and tilt the chair's back to

cause it

to climb up or down stairs.

Physicians and other health professionals must undergo special

training to prescribe the iBOT. The chair must be calibrated to the

patient's weight, and patients have to be trained in its use and

pass

physical, cognitive and perception tests to prove they can operate it

safely.

FDA approved the wheelchair based on a review of extensive bench

testing of the product conducted by the manufacturer, Independence

Technology (a & company), of Warren, N.J., and on a

clinical study of its safety and effectiveness. Approval was also

based on the recommendation of the Orthopedic and Rehabilitation

Devices Panel of FDA's Medical Devices Advisory Committee.

The firm performed a wide range of tests on the chair, including

mechanical, electrical, performance, environmental and software

testing.

In the pivotal clinical study, 18 patients—mostly people with

spinal

cord injury-- were trained to use the iBOT and test-drove it for two

weeks to allow researchers to compare maneuverability, falls and other

problems to those encountered with their regular wheelchairs. They

also tested it going up hills, over bumpy sidewalks, crossing curbs,

reaching shelves and climbing stairs. Twelve patients could climb up

and down stairs alone with the iBOT. The other six patients used an

assistant. When these same 18 patients used their regular wheelchairs,

one patient could " bump " down stairs, but no one could go up even one

step.

During the pivotal study, three patients fell out of the iBOT and two

fell out of their own wheelchairs. None of the falls occurred on

stairs. Two patients experienced bruises while using the iBOT.

As a condition for approval, the manufacturer has agreed to provide

periodic reports to the FDA to document the chair's usage,

functioning

and any patient injuries.

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