Washington

If the U.S Food and Drug Administration heeds the advice of its advisors, wheelchair-bound individuals soon might be able to climb stairs, traverse obstacles and negotiate steep, uneven terrain like never before.

The FDA's Orthopaedic and Rehabilitation Devices Panel Nov. 21 recommended that the administration approve a pre-market application for the Independence iBOT 3000 Mobility System, manufactured by Independence Technology, a subsidiary of X-based Johnson & Johnson.

“This PMA application was granted expedited review status by FDA on Sept. 13, 2002,” the administration's PMA leader wrote. “Expedited review status was granted because FDA believes the device represents a breakthrough technology with a clear, clinically meaningful advantage over existing technologies, and because FDA expects that the device could provide a specific public health benefit in patients with mobility impairments.”

Able to rise vertically to eye-level, the iBOT uses gyroscopic technology to balance on two wheels, according to Independence Technology. The system also features four same-size wheels that rotate up and over one another to climb stairs, according to an Associated Press report.

“This is a highly innovative device for enhancing the mobility capability of people with mobility issues,” said Mark Pinney, chief financial officer of Hawthorne, N.Y.-based Acorda Therapeutics, a company that develops therapeutic products for spinal cord injury and other nervous system disorders. “I think it will have a significant impact. What's not clear, however, is who will buy it.”

While most power chairs are designed for quadriplegics and people without good upper body strength, the iBOT could extend its appeal to paraplegics, who often lead a more vigorous lifestyle, Pinney said.

Pinney also wonders how end-users will pay for the iBOT, which could sell for as much as $29,000. He wonders to what extent third-party payers will reimburse the device.

Dean Kamen, the engineer who invented the iBOT, used similar gyroscopic technology to develop the Segway Human Transporter, a self-balancing personal transportation device designed to allow pedestrians to go farther, move more quickly and increase the amount they can carry.

More information is available at www.fda.gov/ohrms/dockets/ac/cdrh02.htm#OrthopaedicandRehabilitation, under the heading “Orthopaedic and Rehabilitation Devices Panel.”

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