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Tuesday, May 20, 2014
FDA Approves Marketing of Advanced Prosthetic Arm
For the first time, the U.S. Food and Drug Administration (FDA) has given the green light for the marketing of a prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes. These electrodes detect electrical activity from muscle contractions close to where the prosthesis is attached, and the electrical signals are then translated into specific movement(s) by a computer processor in the prosthesis.
The DEKA Arm System, a Defense Advanced Research Projects Agency (DARPA)-funded project intended to restore functionality for individuals with upper extremity amputations, can translate into up to 10 different movements. Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said, “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.”
For this approval, the FDA reviewed survey data and clinical information from a four-site Department of Veterans Affairs (VA) study of 36 participants using the DEKA Arm System. In all, about 90 percent of users reported that they were able to perform new activities that that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair. In one of the studies by the VA, 79 percent of the 24 individuals using the Gen 2 DEKA Arm and 85 percent of the 13 individuals using the Gen 3 DEKA Arm said they would want to receive or might want to receive a DEKA Arm. See additional research on the DEKA Arm here: http://1.usa.gov/QA7GrI.
Justin Sanchez, a program manager in DARPA's biological technologies office, told Reuters that DARPA had provided more than $40 million in funding to DEKA for the development of the prosthetic arm. "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," he said.
Tom Doyon, a project manager at DEKA, said that the company was "proud and excited" about the approval. "This approval allows us to now focus on manufacturing and bringing to market the arm system so that we can deliver it to those in most need of this amazing technology — in particular our wounded veterans."
According to the FDA, the DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. However, it can’t be used for limb loss at the elbow or wrist joint.
The DEKA Arm System is manufactured by DEKA Integrated Solutions in Manchester, N.H.
See previous coverage of the DEKA Arm System in Neurology Today: http://bit.ly/1fV5ZRV, as well as other advances in prosthetics http://bit.ly/nnprosth.