FDA weighs sales of innovative wheelchair

GAITHERSBURG, Md. -- Stairs soon may no longer be insurmountable obstacles for some of the nation's two million wheelchair users.

The first wheelchair that can climb stairs -- plus shift into four-wheel drive to scoot up a grassy hill and even elevate its occupant for eye-level conversation -- took a major step toward the market Wednesday, as advisers to the Food and Drug Administration unanimously recommended it be allowed to sell.

But the panel backed a few limitations on the Independence iBOT 3000 Mobility System -- which uses sensors and gyroscopes to balance on two wheels and navigate stairs -- including that it sell only with a doctor's prescription and strict training to ensure users can drive it safely.

The FDA isn't bound by its advisers' recommendations, but usually follows them -- and it granted the iBOT a special fast-track review reserved for important new medical technology, meaning a decision could come in a few months.

How does it climb? Most wheelchairs have two big back wheels and two smaller front wheels. The iBOT has four wheels the same size that rotate up and over one another to go up and down steps.

Well-known inventor Dean Kamen created the iBOT, and says wheelchair users tell him another feature is as appealing: The chair lifts onto two wheels so that its occupant, although still sitting, is elevated enough to reach high bookshelves and carry on eye-level conversations with people standing nearby.

"One reason I built it was to let people stand up," said Kamen, who licensed the iBOT to Johnson & Johnson. "We treat a lot of adults like children because they can't stand up."

"I wanted to take it home and keep it," said Karl Barnard of Tilton, N.H., who tested the iBOT in a study required by the FDA, which regulates wheelchair safety.

In the iBOT, he rose to the height of a 6-feet-tall person to do his grocery shopping without help. Barnard, who lost use of his legs 25 years ago, has no stairs in his home, but was impressed with the four-wheel drive that let him roll up hills and through gravel on his farm, places his manual wheelchair can't go.

But with a predicted $29,000 price tag, Barnard, 46, calls it "more a luxury item" that he probably wouldn't spring for until he's too old to push his manual wheelchair easily.

While several FDA advisers called the chair potentially revolutionary, they also cautioned that it's not for everyone.

Patients must have the use of at least one arm to operate the chair, moving it with a joystick and other controls, and so far it's built only for large teenagers and adults.