Thursday, November 21, 2002 Posted: 10:54 AM EST (1554 GMT)
A wheelchair that climbs stairs, shifts into four-wheel drive to scoot up hills and even raises occupants to standing height is a step closer to the U.S. market.
Advisers to the Food and Drug Administration unanimously recommended approval of the souped-up wheelchair, called the Independence iBOT 3000 Mobility System, on Wednesday.
Some of them called the iBOT, which uses sensors and gyroscopes to balance on two wheels and navigate stairs, potentially revolutionary. But the panel did urge a few limitations to ensure patients can use the complex technology safely -- such as a doctor's prescription and special training to drive it.
"After decades of work, it looks like it's finally paying off," said Dean Kamen, the well-known inventor who created the iBOT and licensed it to Johnson & Johnson.
The FDA, which regulates wheelchair safety, isn't bound by its advisers' recommendations, but usually follows them. It granted the iBOT a special fast-track review reserved for important new medical technology, meaning a decision could come in a few months.
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.
The chair also 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.
"I wanted to take it home and keep it," said study participant Karl Barnard of Tilton, New Hampshire, who could rise 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 iBOT's four-wheel drive that let him roll up hills and through gravel on his farm.
But with a predicted $29,000 price tag, Barnard, 46, calls it "more a luxury item" that he probably won't spring for until he's too old to push his manual wheelchair easily.
The chair is not for everyone, the FDA advisers cautioned. Patients must have the use of at least one arm to operate it, and so far it's built to seat only adults and large teenagers.
Also, it requires some exertion: Users lean forward or backward, directing the chair to go up or down as it senses and adjusts to the person's center of gravity. They must hold onto a stair rail while going up and down stairs, although someone else can hold onto the chair back to assist the more severely disabled on stairs.
Picking the right patient is crucial -- someone who not only is physically capable of handling the iBOT, but has the right judgment skills to discern obstacles, such as which hills are too steep to try climbing, without risking serious falls, said Dr. Steve Stiens, a University of Washington rehabilitation specialist who uses a wheelchair himself.
Sales will be strictly controlled, responded manufacturer Independence Technology, a J&J subsidiary. Doctors and rehabilitation therapists must undergo special training to prescribe the iBOT, and potential users would have to pass a test proving they can drive it safely before taking it home.
Twenty wheelchair users test-drove iBOT for two weeks, allowing scientists to compare maneuverability, falls or other problems with their regular wheelchairs. They also took a road test, scooting up hills and over bumpy sidewalks, crossing curbs, reaching shelves and climbing stairs.
The patients performed most of the challenges more easily with the iBOT, said study leader Dr. Heikki Uustal of New Jersey's Johnson Rehabilitation Institute.
Three people fell out of the iBOT and two fell out of their own wheelchairs during the study, suggesting the iBOT was as safe as today's technology.
The iBOT's price is less than some top-of-the-line models for the severely
impaired, but far more than basic chairs. But Independence Technology president
Jean-Luc Butel said the average cost for ramps, elevators and other home
modifications for someone unable to walk is $40,000, expenditures largely
unnecessary with the iBOT. He is negotiating with Medicare and other insurers
to pay for the iBOT.
© Copyright 2002 Reuters