After years in the making, the LUKE arm is the first fully integrated prosthetic arm for amputees across a range of levels of amputation.

Nancy Crotti

Two military veterans who participated in clinical trials that supported FDA clearance of the LUKE arm have received the motorized prosthetic device.

One year after announcing its motorized prosthetic LUKE arm would be available for sale, Mobius Bionics has its first two patients.

Two military veterans who participated in clinical trials have received the prostheses, courtesy of the U.S. Department of Veterans Affairs. Mobius is a manufacturing spinoff of DEKA Research & Development Corp., which developed the LUKE arm with funding from the Defense Advanced Research Projects Agency (DARPA).

FDA cleared the LUKE arm in 2014 as the first fully integrated prosthetic arm for amputees across a range of levels of amputation, including shoulder-level, above-elbow, and below-elbow. The shoulder-level configuration includes the first commercially available powered shoulder, enabling its users to reach above their heads or behind their backs, and pick up a bag of groceries or pour a glass of milk for themselves, often for the first time since they lost their arm, according to Mobius.

The company has been putting manufacturing and shipping capabilities in place while working with the VA, DARPA and private prosthetists to identify good candidates for the arm, said Jay Burkholder, Mobius' general manager. Universal Instruments, Rochester, NY, is the contract manufacturer doing the primary assembly work.

One of the first recipients is Fred Downs, a prosthetics consultant for the Paralyzed Veterans of America who lost his left arm above the elbow during the Vietnam War to a "Bouncing Betty" land mine. The other is Army veteran Artie McAuley, who lost his arm in an accident while stationed at Fort Drum, NY. McAuley did not use a prosthesis for many years because earlier options available to shoulder-level amputees did not provide enough functionality, according to Mobius.

Downs and McAuley had tried multiple versions of the LUKE arm over several years during the development phases, including take-home studies that were used to support Mobius' FDA filing, Burkholder said.

"DARPA funded these first two arms in order to ensure that we could get them fit in a timely basis, but we're working on a long-term, significantly higher-volume contract with the VA now," he added. "We're very happy that the VA has started distributing these things and we expect things to take off fairly quickly from here."

Pricing for the LUKE arm depends upon the needs of each individual recipient as well as the fitting process and follow-up visits to the prosthetist, Burkholder said. The prosthetist must create a socket to mount the arm in, set up the controls, give the initial training and provide support if the arm needs adjustment, he explained.

The LUKE arm is also available to non-veterans as well. Mobius has a number of clients who are working to get their insurance companies to pay for the LUKE arm.

"A lot of it has to justify to the insurance companies that there is no other prosthesis that can restore the person's functionality as well as the LUKE arm," Burkholder said. "That justification takes time."

Nancy Crotti is a contributor to Qmed.

[Image credit: Mobius Bionics LLC]