A Medical Device Daily

Victhom Human Bionics (Quebec City, Quebec) reported that its Neurobionix division has obtained CE-mark approval for its Neurostep System, which it said is the first approval for a closed-loop system (CLS) used on peripheral nerves.

The Neurostep is an investigational implantable neuromodulation product designed to treat gait disorders such as foot drop). Victhom said it is the first CLS product aimed at using the patient's own nervous system as the source for detection of intention to move and control their leg.

"Accomplishing CE-mark approval is the latest step in what continues to be the steady advance toward commercialization of the Neurostep," said acting president Normand Rivard. "These recent accomplishments are an indication of our commitment to this business and the ability of the company to deliver on its scientific and business objectives."

Unlike other systems that use surrogates such as external sensors, the company said the Neurostep "detects intrinsic muscle activities and surface sensation events from the nerve signals delivered to the spine and brain. This information is then used as the trigger for intervention through neurostimulation, as needed, to complete function"

In a press release on the European approval of the device, the company said, "We believe that patients implanted with the Neurostep will experience remedy to their foot drop and an improved walking pattern that should contribute to give them more independent mobility and a healthier lifestyle."

CE-mark approval gives Neurobionix the ability to train and educate physicians in preparation for market release of the Neurostep System in the European Union, which is planned for late 2009.

The company said the clearance to enter the European market allows it to increase its market development activity by identification and education of hospitals and physicians that would introduce this new solution to patients in the most expedient manner.

"The approval of the Neurostep System marks a major milestone in the repositioning of the Neurobionix division into a full function organization that can develop and deliver products of a distinctive value for the market," said Nader Kameli, COO of the Neurobionix division.

He added, "We feel confident that we can build on this success to enable commercial launch of the Neurostep System in the European market in 2009."

The Neurostep System is not currently available in the U.S., but Victhom said it is planning to engage with the FDA to pursue plans for bringing this new solution to American patients.

Victhom is a developer of bionic devices involved in the treatment of a variety of physical and physiological dysfunctions. The Neurobionix division focuses on the development and commercialization of technologies and products involving implantable devices that feature neurosensing and neurostimulation components, integrated with artificial intelligence.

The company's Biotronix division develops biomechatronic products to support or replace peripheral limbs in the orthotics and prosthetics market.

'Groundbreaking' tech from Welsh engineers

The XGEN consortium, a Welsh Assembly government initiative that unites three of Wales' leading engineering organizations, reported that it is on course to tackle one of the major challenges facing the medical industry – control over artificial limbs in severely disabled spinal injury patients or loss-of-limb patients via direct readings of the brain.

Dr. Robert Hoyle of MicroBridge Services, part of the XGEN consortium; the technology for helping patients improve their ability to take signals from the human brain and translate those signals into motion in the artificial limb is getting closer.

"We have been collaborating with researchers and medical practitioners who are testing our micro-needle array sensors in the field which we believe one day will have a massive impact on the future functionality of severely disabled or loss-of-limb patients," he said.

"In the majority of amputations nowadays, nerves that normally control the arm muscles are surgically relocated to the chest muscles and the electrodes are then able to pick up nerve impulses being sent out to the no-longer-existing arm muscles," Hoyle said. "The problem with this solution is that it doesn't work with patients without nerve endings, such as patients with cervical injuries, so the greatest challenge the industry currently faces is finding a way to control a prosthetic limb using readings from the brain. And this is where our technology comes to the fore."

According to Hoyle, XGEN's micro electro discharge machining (micro EDM) is ideal to help with medical procedures on one of the critical components of the brain/machine interface, the sensor electrode array, which sits as an implant in the surface of the brain.

The XGEN consortium was established in April 2007. The three centers that unite under the XGEN brand are LML, MicroBridge Services Ltd. and metaFAB.

Think FAST on stroke

The UK Department of Health is launching a three-year, £12 million awareness campaign to help the public recognize the signs of stroke, using the simple FAST test.

The acronym stands for:

— Facial weakness. Can the person smile? Has his or her mouth or eye drooped?

— Arm weakness. Can the person raise both arms?

— Speech problems. Can the person speak clearly and understand what you say?

— Time to call 999. If the person shows any one of these signs, call an ambulance.

Stroke is the third most common cause of death in the UK. Each year, 150,000 people have a stroke and of those, 67,000 die. The Department of Health emphasized that stroke can happen to anyone, young or old, at any time. It said that 25% of those who have a stroke are under retirement age.

Direct stroke care costs the National Health Service £2.8 billion a year, and the wider economy another £1.8 billion in income and productivity losses as a result of disability.

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