Those with spinal cord injuries may now look at getting robotic legs after the Food and Drug Administration announced its approval of the marketing of them, according to a press release from the agency.
These motorized devices are meant to be like an exoskeleton that will improve mobility for paraplegic individuals that have no movement below the waist as a result of spinal cord injuries. The FDA mentioned a device called ReWalk. This apparatus is worn over legs and some of the upper body and enables paraplegics to sit, stand and walk. Currently, ReWalk is used with assistance from a trained aide, according to the FDA. The aide could be a spouse or companion.
The robotic legs provided from ReWalk are equipped with motion sensors and joints that are motorized to provide the manufactured mobility of actual legs. They respond to slight changes in the body, such as muscle movement in the upper body and changes in balance, a significant feat in health-related technology.
The federal regulators have explained that a harness may be worn around the waist and shoulders of the patient, which helps keep the robotic legs and suit in place correctly. Crutches also provide stability for the device. A backpack holds the necessary computer equipment and power supply for the medical device. It can be controlled using a remote-control device conveniently worn on the patient's wrist.
The robotic legs were developed by the founder of Argo Medical Technologies, based in Israel. His name is Amit Goffer and he was paralyzed in an automobile accident in the late 1990s.
According to the U.S. Centers for Disease Control and Prevention, about 200,000 people in the United States live with a spinal cord injury. A significant number of them have partial or total paraplegia. This device can be alternatively used in rehabilitation centers, but it is not intended for recreational purposes, the FDA warned.
The FDA also issued warnings for those with a history of neurological injuries beyond spinal cord. They issued warnings for other types of conditions and medical history as well, including an unstable spine, severe spasticity, contractures and limb fractures or pelvic fractures that have not healed yet. Patients are also advised never to use the robotic legs if they have heart or lung conditions, concurrent infections, circulatory conditions or pressure sores that may get worse as they use the ReWalk device.
The FDA also explained caregivers and patients alike must train to learn how to use the robotic legs device. The training program was developed by the manufacturer of the device. Data from 30 study participants was used to determine the safety and effectiveness of the device, according to federal regulators.