The United States Food and Drug Administration (FDA) has approved ReWalk Robotics‘ personal exoskeleton for marketing in the U.S for those whose lower body is paralyzed from a spinal cord injury
The $69,500 motorized, robotic device is worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion. It weighs 46 pounds, supporting its own weight, and has metal braces, a motor, and a 5-pound backpack that houses the computer and battery.
ReWalk is designed for users between 5-foot-3 and 6-foot-3 with a weight limit of 220 pounds.
Users wear a wrist device that has buttons on it that can engage three modes: standing, sitting and walking. The exoskeleton’s computer runs on Windows and delivers the control signals.
ReWalk says the battery currently is designed to support a full day of intermittent walking. If the user walks non-stop, the battery will last three to four hours.
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” says Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
Health insurance in the U.S. doesn’t cover the ReWalk, so it’ll come with a hefty price tag. ReWalk CEO Larry Jasinski recently told Mashable, however, the company is “working with insurers and other healthcare coverage providers to ensure individuals eligible to use the ReWalk are able to purchase a system.”
Putting ReWalk to the Test
To assess safety and effectiveness of ReWalk, the FDA reviewed testing done to assess ReWalk’s durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.
The FDA also reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’ ability to walk various distances, the amount of time needed to walk various distances, performance on various walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Studies also assessed the risk of certain physical effects on the user. Additionally, observational data from 16 patients were also provided to support use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion. Risks associated with ReWalk include pressure sores, bruising or abrasions, falls and associated injuries, and diastolic hypertension during use.
The FDA reviewed the ReWalk through its de novo classification process, a regulatory pathway for novel, first-of-its-kind medical devices that are generally low- to moderate-risk. The FDA is requiring Argo Medical Technologies, Inc., the manufacturer of ReWalk, to complete a post-market clinical study that will consist of a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training program.