A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported receipt of CE-mark approval of its Libra and LibraXP deep brain stimulation (DBS) systems for treating the symptoms of Parkinson's disease. The limited launch of these systems in Europe represents St. Jude Medical's initial foray into the DBS market.

The company said the Libra systems "function in a manner similar to a heart pacemaker by delivering mild electrical pulses from an implanted device to stimulate structures in the brain that are involved in muscle and movement control." Stimulation is delivered to one of two regions in the brain known as the subthalamic nucleus or the globus pallidus interna to influence nerve cell activity in these regions.

"The approval of our first deep brain stimulation system represents the fulfillment of a milestone for St. Jude Medical as we continue to deliver on our promise to develop therapies to treat neurological conditions," said Chris Chavez, president of St. Jude's Neuromodulation Division.

The Libra and LibraXP neurostimulators are constant-current devices that the company said feature the largest battery capacity of any DBS device in their class, which may maximize the time between device replacement procedures. The therapy can be non-invasively adjusted by a clinician to meet individual patient needs.

"We have a long history in the development of neurostimulation therapies, with more than 45,000 people implanted with our devices for chronic pain," said Chavez. "We look forward to providing physicians with this innovative deep brain stimulation system that allows them to better control the symptoms of this debilitating disease."

St. Jude entered the neurostimulation space with its 2005 acquisition of Advanced Neuromodulation Systems (Plano, Texas). Chavez was president/CEO of that firm and became president of the new St. Jude division upon completion of the deal.

Parkinson's disease affects an estimated 6.3 million people worldwide, according to the European Parkinson's Disease Association. The National Parkinson's Foundation estimates that one in every 100 people in the U.S. over the age of 65 has the disease.

St. Jude said a recent study published in the Journal of the American Medical Association concluded that DBS was a more effective treatment than best medical therapy for the management of moderate-to-severe Parkinson's disease.

The company is developing additional DBS applications, with clinical studies underway in the U.S. for depression, essential tremor and Parkinson's.

First German patients treated with RapidArc

Three prostate cancer patients have become the first persons in Germany to be treated using a new, faster form of radiotherapy that potentially enables doctors to improve outcomes while extending more advanced care to more patients. The faster treatment using RapidArc radiotherapy technology from Varian Medical Systems (Palo Alto, California) was delivered at Sudharz Krankenhaus (Nordhausen, Germany).

Varian said RapidArc "delivers a precise and efficient treatment in a single or multiple arcs of the treatment machine around the patient and makes it possible to deliver advanced image-guided intensity modulated radiotherapy (IMRT) two to eight times faster than is possible with conventional IMRT."

At Sudharz Krankenhaus Nordhausen, doctors have been able to reduce the treatment time to just 2-1/2 minutes compared with up to 30 minutes for complex IMRT treatments.

"It is very gratifying for me to begin treatments using the most modern moving arc method of radiotherapy," said Wolfgang Oehler, MD, head of the radiotherapy department. "The three patients are excited to be the first in Germany to receive such treatments although the treatment was so quick that one patient questioned whether he had received the full dose."

Oehler said RapidArc was a valuable weapon in the hospital's goal of bringing down waiting lists. "We knew we needed a ... new method of shortening treatment times and avoiding waiting lists while improving the quality of the treatment and it was not a hard decision to select RapidArc," he said.

Sudharz Krankenhaus treats up to 900 patients a year using two Varian Clinac linear accelerators. The hospital pioneered advanced IMRT treatments in Germany, carrying out the country's first such treatment in June 2001 and treating an additional 2,733 patients with the highly conformal technique in the eight years since.

With RapidArc, Varian's Clinac accelerator can target radiation beams at a tumor while continuously rotating around the patient. Conventional IMRT treatments are slower and more difficult for radiotherapy radiographers because they target tumors using a complex sequence of fixed beams from multiple angles.

NHS in big carbon footprint push

The National Health Service (NHS) has pledged to become one of England's leading sustainable and low-carbon organizations and to meet the UK government's target of an 80% reduction in carbon emissions by 2050.

The pledge is set out in a new strategy, "Saving Carbon, Improving Health," which was to be launched today by NHS Chief Executive David Nicholson, and NHS Sustainable Development Unit Director Dr. David Pencheon.

The NHS has a carbon footprint of 18 million tons of CO2 per year – 3.2% of carbon emissions and 25% of public sector emissions in England. As part of the newly announced strategy, NHS organizations are committing to reducing their carbon footprint.

Each organization will determine how it does so and set its own targets. The NHS has set a goal of achieving a 10% reduction in its 2007 carbon footprint by 2015. "This will require the current level of growth of emissions to not only be curbed, but the trend to be reversed and absolute emissions reduced," Nicholson said.

Pencheon said, "Carbon reduction is something that needs to extend to every part of the organization. Everyone who works for the NHS should be thinking about reducing their carbon footprint as part of their day job."

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