FDA Clears Robotic Legs For Paralyzed Patients

 

The FDA announces that it has approved new wearable robotic technology from maker Argo Medical Technologies for use by paralyzed patients. In the announcement, the FDA calls the device “first wearable, motorized device that helps people with certain spinal cord injuries walk again.”

The ReWalk device runs from a brace worn around the hips and extends down the users legs, connecting with straps and clips around the thigh, knee, calf, and around the feet. The wearable exoskeleton provides motorized movement to the hips, knees, and ankles which allows users to walk indoors, outdoors, and on uneven terrain. Users carry a cane in each hand for balance and support, and a backpack that houses both a battery, and a computer that receives commands from the user’s controller and engages the motors accordingly.  Wearers use a wireless, wrist-worn, remote control to instruct ReWalk to sit, stand, or walk. ReWalk also reports that the battery holds enough power to support use for an entire day.

The ReWalk website claims that its users are able to climb stairs with the help of the robotic legs, however, the FDA’s announcement explicitly notes that ReWalk is not for use on stairs, leaving patients to decide for themselves whether they’ll trust the new device on stairs or not. The FDA evaluated ReWalk through its de novo classification process, a clearance pathway that removes some red tape for first-of-its-kind products that pose low to moderate risk to patients. As part of its evaluation of ReWalk’s robotic legs, the FDA monitored 30 study participants as they used the device in various environments. Performance was tracked and risk levels were evaluated for specific tasks that evaluators felt might pose a higher risk, such as walking on a sloped terrain, and walking on uneven surfaces. After completing its assessment, the FDA concluded that ReWalk’s robotic legs were not an appropriate for use on stairs. Without the ability to climb stairs, paralyzed patients will likely find that they are still forced to rely on handicapped ramps and elevators for access in public spaces.

ReWalk has been available in Europe, where regulatory barriers for new medical devices are less rigid, for several years. In the US, sales of the ReWalk robotics legs system are now approved, but only after both the user and an friend or assistant complete approved training. Argo has also agreed to complete a post-market clinical trial of the device and the training program to screen for adverse events and to ensure that the training is meeting the patient’s needs. The device is expected to retail for $65,000.


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