The FDA said on Friday it allowed the sale of the DEKA Arm System after reviewing data, including a U.S. Department of Veterans Affairs study in which 90 percent of people who used the device were able to perform complex tasks. These included using keys and locks, feeding themselves, using zippers and brushing and combing hair.
The prosthetic arm was developed by New Hampshire-based DEKA Research and Development Corp, founded by Dean Kamen, the inventor of the Segway and other devices.
The Pentagon's Defense Advanced Research Projects Agency (DARPA) said it provided more than $40 million in funding to DEKA to develop the robotic arm as part of a $100 million project to improve prosthetics. "It was designed to produce near-natural upper extremity control to injured people who have suffered amputations. This arm system has the same size, weight, shape and grip strength as an adult's arm would be able to produce," Justin Sanchez, a program manager in DARPA's biological technologies office, said in a telephone interview.
The FDA said the device is the first prosthetic arm that can carry out multiple, simultaneous movements controlled by signals from electromyogram electrodes that detect electrical activity caused as a person contracts muscles.
The electrodes send signals to a computer processor in the arm, which can then make up to 10 specific movements using a combination of switches and sensors.
"The DEKA Arm System may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement. The Pentagon's involvement came about because of the type of injuries sustained by U.S. troops in the Iraq and Afghanistan wars. The Pentagon said more than 1,800 U.S. service members underwent major limb amputations as a result of injuries sustained in those wars.
"This prosthetic limb system can pick up objects as delicate as a grape, as well be able to handle very rugged tools like a hand drill," Sanchez said.
Until now, the best technology available to troops and other who lost an arm was a metal hook, Sanchez said. "The metal hook was the most commonly used prosthetic device for the last hundred years."
DEKA said on its website that the arm is dubbed "Luke" after Luke Skywalker, the character whose hand is sliced off in a duel and is replaced with a robotic version in the 1980 film "The Empire Strikes Back."
The FDA said the robotic arm could be used by people with limb loss occurring at the shoulder joint, mid-upper arm or mid-lower arm, but not at the elbow or wrist joint.
In the Veterans Affairs study, 36 people provided data on how the arm performed in common household and self-care tasks.