Prosthetic arm from Segway inventor approved by FDA

A prosthetic arm made by a company founded by Segway inventor Dean Kamen was approved for sale by U.S. regulators, who called it the first such device able to respond to multiple simultaneous commands from a wearer's brain.

Electrodes attached to the arm detect muscle contractions close to the prosthesis, and a computer translates them into movement, the U.S. Food and Drug Administration said today in a statement. As many as 10 movements can be detected by the limb, which is the same weight and shape as a natural human arm.

The company, closely held DEKA Research and Development Corp. of Manchester, New Hampshire, developed the arm with financing from the U.S. Defense Advanced Research Projects Agency and the U.S. Army Research Office, according to DEKA's website. The company nicknamed the arm "Luke," after the "Star Wars" movie character Luke Skywalker, who receives a bionic hand after losing his natural one in a light saber battle with his father, Darth Vader.

"Think about our military personnel, who can be great beneficiaries of these devices: before DARPA made an investment in this area the best we could give back to them was metal hooks," Justin Sanchez, a program manager in the agency's new Biological Technologies office, said in a phone interview. "This is a landmark moment for DARPA as an agency."

The DEKA limb can provide "near natural upper-arm extremity control" to amputees and the device is modular so that it can be fitted to people who've suffered any degree of limb loss, from an entire arm to a hand, Sanchez said. Six "grip patterns" allow wearers to drink a cup of water, hold a cordless drill or pick up a credit card or a grape, among other functions.

DARPA has given DEKA $40 million since 2006 to develop the arm, Rick Weiss, a spokesman for the agency, said by phone. DEKA owns the patents and commercial rights for the device.

The limb won't be available for sale and a price won't be determined until DEKA finds a commercial partner to mass- manufacture it, said Matt Albuquerque, president of Next Step Bionics & Prosthetics Inc. in Manchester, New Hampshire, which helped DEKA develop the device. DARPA's money was crucial to attract Kamen to the project, Albuquerque said, calling him "probably one of our generation's greatest inventors."

"Without that kind of money it would be difficult to attract the kind of people I think that we need to solve the problem we're trying to solve," he said.

A DEKA spokeswoman didn't return a phone call and e-mail seeking comment on FDA's approval.

Flexing Muscles

The limb works by attaching electrodes to the surface of remaining arm or shoulder muscles, or to the legs of amputees, Albuquerque and Sanchez said. When amputees flex the muscles that would have previously been involved in moving their arm or fingers, the DEKA limb moves accordingly.

"They don't need to control the shoulder, the elbow and the hand; it's all able to work together in one motion," Albuquerque said.

Alternatively, the limb can be controlled with leg movements, Sanchez said. Signals are transmitted wirelessly.

"The research down the road is when something is implanted in the muscle, and a signal is wirelessly transferred to the arm," Albuquerque said. "That's really the beginning of the $6 million man."

To contact the reporter on this story: Alex Wayne in Washington at awayne3bloomberg.net To contact the editors responsible for this story: Reg Gale at rgale5bloomberg.net Andrew Pollack, Angela Zimm