Stair-Climbing Wheelchair Works, FDA Staff Says

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Stair-Climbing Wheelchair Works, FDA Staff Says

WASHINGTON (Reuters) - & 's iBOT wheelchair, which climbs

stairs and traverses tough terrain, was effective in a clinical trial, U.S.

regulatory staff said ahead of Wednesday's key review of the product.

The study of 20 patients showed people were able to perform tasks better

with the battery-powered iBOT than with their own wheelchairs, Food and Drug

Administration (news - web sites) reviewer Marie Schroeder said in a review

posted on the agency's Web site.

The trial had some limitations, however, Schroeder said, noting that some

speeds and functions were not tested extensively.

An FDA advisory panel, a group of experts from outside the agency, is

scheduled to meet Wednesday to review & 's data and vote on

whether to recommend approval for the new wheelchair. The FDA usually

follows its panels' advice.

The iBOT, conceived by prolific inventor Dean Kamen, uses gyroscopes to

mimic the way people maintain their balance. The chair can maneuver up and

down stairs and curbs, go into four-wheel drive mode to navigate beaches or

grass and rise on two wheels to bring a user to eye level.

The wheelchair's cost is expected to be about $29,000, &

spokeswoman Odenthal said.

The FDA's Schroeder said the iBOT " tended to be less maneuverable in the

home but more maneuverable in the community as compared to subjects' own

mobility devices. "

Two people suffered bruises during the trial, Schroeder said.

" It is not clear whether additional risks will be demonstrated with

long-term use of this device in users' homes and communities as long-term

safety and effectiveness data are not available, " Schroeder wrote.

& shares were up 11 cents at $59.19 in morning trading.