2002-11-19 13:05:02 -0400
Johnson & Johnson's iBOT wheelchair, which climbs stairs and traverses tough terrain, was effective in a clinical trial, US 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 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 Johnson & Johnson'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, Johnson & Johnson spokeswoman Susan 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.
Copyright © 2002 Reuters Limited