Some are calling it the “Terminator” hand, although its manufacturer, Touch Bionics (Livingston, Scotland), prefers to promote the first commercially available bionic hand as the i-Limb Hand.

Veterans of the Iraq war, who are among the first to be outfitted with the hand and its powered fingers, say they actually prefer the naked mechanism which gives it an eerily Terminator-like look, not bothering with the protective skin-like covering intended to make it more life-like.

Since its late-July launch at the 12th World Congress of the International Society for Prosthetics and Orthotics (ISPO; Copenhagen) in Vancouver, British Columbia, Touch Bionics said it has been inundated with orders for the device and unqualified endorsement from amputees.

Medical Device Daily caught up with Touch Bionics CEO Stuart Mead recently at the U.S. Army Forces Command Medical Leaders Training Course in Atlanta.

“It is not just the sales, it is the customers that are significant for us,” Mead told MDD. “And right now we are receiving inquiries but especially orders from the U.S. military, Veterans Affairs and the UK military.”

He said that while the military has greatly improved armor, “the extremities are not well-protected,” which explains what brought Touch Bionics to the military medical care meeting in Atlanta.

Mead told MDD that the prosthetics giant Otto Bock Health Care (Duderstadt, Germany) already has responded to the market, saying it is developing a hand to compete with Touch Bionics.

A prosthetic hand with five individually powered fingers, the i-LIMB Hand offers a unique, highly intuitive control system that uses a traditional two-input myoelectric signal to open and close the hand’s life-like fingers. The engineering enhances dexterity and creates new grip options for users.

Myoelectric controls utilize the electrical signal generated by muscles in the remaining portion of a patient’s limb. This signal is picked up by electrodes that sit on the surface of the skin.

Users of existing, basic myoelectric prosthetic hands are able to quickly adapt to the system and can master the device’s new functionality within minutes, the company says.

One British man and 13 amputees in the U.S. have been fitted with the device during trials.

One of the recipients of the hand is Sgt. Juan Arredondo, 2nd Infantry Division, from Universal City, Texas, who lost his hand in Iraq in 2004 after his patrol vehicle was struck by an explosive device.

“Every day that I have the hand, it surprises me,” Arredondos said. “Now I can pick up a Styrofoam cup without crushing it. With my other myoelectric hand, I would really have to concentrate on how much pressure I was putting on the cup,” he said, adding, “The i-LIMB hand does things naturally. I can just grab the cup like a regular person.”

Not everyone wants the “Terminator” look for their hand, so custom cosmesis, or a skin-like covering, “is a hugely important area in prosthetics, both for appearance and for durability reasons,” according to Mead.

Touch Bionics has reported partnerships with ARTech Laboratories (Midlothian, Texas) and Livingskin (Middletown, New York) to offer patients life-like coverings for the bionic hand.

Touch Bionics also launched in Vancouver a partial hand, ProDigits, adapted for patients who have a partial hand, due either to congenitally missing fingers or fingers lost through an accident.

Mead told MDD that the next product launch will be for a full arm, powered from shoulder to wrists. A prototype of the unit was demonstrated at the ISPO congress, he said.

(And Mark McCarty, MDD’s Washington editor, recently reported on the Vanderbilt artificial arm, being developed at Vanderbilt University, supported by DARPA funding [MDD, Aug. 30, 2007])

Touch Bionics was spun out from the UK’s National Health Service in early 2003 as Touch EMAS, EMAS for Edinburgh Modular Arm System. After significant investment from Scottish Health Innovations (Glasgow), the company was re-branded as Touch Bionics in 2005.

The i-Limb Hand retails for $18,000, twice the price of the average prosthetic, according to Phil Newman, head of sales and marketing at Touch Bionics.

“We plan to stay out of the wider public domain for a little while longer as we identify and engage with the right partners to support our U.S. market entry and growth,” Newman said.

Mead told MDD that military customers have been quicker to win approvals for reimbursement and that the company’s sales projections reflect an anticipated delay before public and private insurers provide reimbursement.

“We are very much on target with projections,” he said.

An advantage for Touch Bionics’ design innovations is that individually powered finger can be removed with one screw by a prosthetist who can then swap out fingers that require servicing. Traditional devices would have to be returned to the manufacturer, often leaving the patient without a hand for many weeks, the company said.

Sanofi-Aventis sued for patent violation

The Swiss contract manufacturer for insulin injection pens for Sanofi-Aventis (Paris) has sued the world’s third-largest pharmaceutical group for breach of patent over the SoloSTAR line of pens.

Ypsomed (Burgdorf, Switzerland), which derives 55% of its revenues from production of Sanofi-Aventis pens, filed suit in Germany saying the pharma giant should stop production of SoloSTAR pens and pay damage and interest for its fraudulent use of the patent.

“As a partner for over 20 years, Ypsomed informed Sanofi-Aventis at an early stage of the patent breaches in connection with the SoloStar pen,” said Ypsomed Chairman Willy Michel, who added, “Negotiations have not as yet led to an acceptable outcome.”

The two companies remain tightly connected by contracts for manufacture of the OptiSet, OptiClik and OptiPen Pro insulin pens.

Sanofi-Aventis also is being sued in the U.S. by Novo Nordisk (Bagsv rd, Denmark), which says SoloStar infringes on its patent for an injection device.

Sanofi-Aventis introduced the SoloSTAR disposable injection for pens in Germany in April and is progressively rolling out distribution in other European markets throughout 2007 (MDD; March 27, 2007). The new SoloSTAR line of pens won approval for U.S. distribution in May (MDD; May 7, 2007).

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