June 27 (Bloomberg) -- The first robotic device that acts as legs to help paraplegics walk was approved for the market by U.S. regulators.
The device, called ReWalk, is a motorized “exoskeleton” approved for those whose lower body is paralyzed from a spinal cord injury, the Food and Drug Administration said yesterday in a statement. The product, from closely held Argo Medical Technologies Inc., consists of a fitted, metal brace; motors at the hips, knees and ankles; and a backpack that contains the computer and power supply.
About 200,000 people in the U.S. are living with a spinal injury, according to the Centers for Disease Control and Prevention. ReWalk weighs 46 pounds, only 5 pounds of which users feel from the backpack, according to Argo, based in Marlborough, Massachusetts. The personal system costs $69,500, the company said.
“For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials,” Larry Jasinski, Argo Medical’s chief executive officer, said in a statement.
Patients use crutches to provide additional stability and a remote control on their wrist to command ReWalk to stand, sit or walk, the FDA said. The device is custom-fit for each user, and patients and their caregivers must undergo training to use the product.
The device was developed by Argo Medical founder Amit Goffer in 2001 after he was paralyzed in an accident with an all-terrain vehicle, according to the company’s statement. ReWalk has been available in Europe since 2012.
Candidates for the device have spinal cord injuries at levels T7, the seventh thoracic vertebra, to L5, the fifth lumbar vertebra. A rehabilitation version is approved for people with injuries at levels T4, the fourth thoracic vertebra, to T6, the sixth thoracic vertebra.
The FDA cleared ReWalk through its process for novel devices that are considered low- to moderate-risk. Patients shouldn’t use the device if they have a history of severe neurological injuries other than spinal cord injury or other medical issues such as infection or heart or lung conditions, the FDA said.
Argo Medical will use a registry of patients to collect data on adverse events as a condition of FDA’s clearance, the agency said. Risks associated with the device include pressure sores, bruising, falls and hypertension.
“Innovative devices such as ReWalk go a long way toward helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health.