A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported CE mark approval of the Brio neurostimulator, which it said is the world's smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson's disease.

A 67-year-old man who has suffered from Parkinson's disease for more than 26 years became the first person to be implanted with the Brio neurostimulator.

Slightly larger than the typical man's watch, the Brio neurostimulator has a thin 10 mm profile and weighs 29 grams (about 1 oz). Additionally, the device has the greatest recommended implant depth of any rechargeable DBS device. The thin profile and greater implant depth potentially makes the neurostimulator less noticeable and more comfortable for patients.

"Deep brain stimulation therapy is often the preferred treatment for many Parkinson's disease patients," said Professor Volker Sturm, MD, chairman of neurosurgery at the University Hospital of Cologne (Cologne, Germany). "For these patients, device size and longevity are important considerations. The small size of the Brio neurostimulator is a real improvement and was a good choice for this patient."

The procedure was performed by Professor Sturm's colleague, Mohammad Maarouf, MD, at the University Hospital of Cologne.

The Brio DBS system delivers mild electrical pulses to specific targets in the brain, stimulating the structures that are involved in motor control. The system consists of a neurostimulator – a surgically implanted battery-operated device that generates the electrical pulses – and leads which carry the pulses to the brain to influence the irregular nerve signals responsible for the symptoms of Parkinson's disease.

"The Brio neurostimulator is an important addition to our family of deep brain stimulation systems," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "We are excited to offer physicians a best-in-class product to help them meet the needs of patients who require a smaller, long-lasting rechargeable system in order to better control the symptoms of this debilitating disease."

In addition to its small size, the company said the Brio has the longest battery life of any rechargeable DBS device currently on the market with a 10-year battery longevity approval. For patients this means the device should provide sustainable therapy and maintain a reasonable recharge interval for at least 10 years of use at high settings. The device's battery longevity may also maximize the time between device replacement procedures.

Parkinson's disease affects an estimated 6.3 million people worldwide, according to the European Parkinson's Disease Association. The disease usually develops in people between the ages of 40 and 70, with an average age of onset of 60 years.

St. Jude Medical is also currently developing new DBS applications to address a growing list of neurological and psychiatric disorders. Clinical studies are underway in the U.S. for depression and essential tremor.

Stratatech launches human skin model

Stratatech (Madison, Wisconsin), a privately-held regenerative medicine company, reported that it will launch its StrataTest full-thickness human skin model to the European market at Eurotox 2009, the annual meeting of the Federation of European Toxicologists and the European Societies of Toxicology. This year's meeting is being held in Dresden, Germany, Sept. 13-16.

Composed of both an epidermis and a dermis, the StrataTest full-thickness human skin model displays the physical, chemical and histological characteristics of native human skin. The tissue is readily available, reliable and is supplied in an easy-to-use, 24-well format for consumer product testing, drug discovery and toxicity screening.

The StrataTest human skin model, which is intended for research use only and is in early-state ECVAM (European Center for the Validation of Alternative Methods) validation, is manufactured using Stratatech's proprietary and clinically-tested NIKS human keratinocytes. NIKS cells, which have been shown to be pathogen-free and non-tumorigenic, consistently produce a fully-stratified, multi-layered human skin substitute tissue in each well of the StrataTest test plate. Each tissue grows as new, native human skin does, replicating its structure and function.

IBA selects Elekta software for proton therapy

Elekta (Stockholm, Sweden) will provide treatment planning and information management systems for a major proton therapy facility in Prague, Czech Republic.

Elekta is a provider of software solutions in the proton therapy market, as evidenced by its inclusion in an international proton therapy site, the Proton Therapy Center Czech in Prague.

The Center will be equipped with Mosaiq, an intuitive, yet powerful oncology information system that increases process efficiency, allows real-time access to clinical information and facilitates the highest quality patient care.

"The workflow-centric approach of Mosaiq will lead to increased patient comfort during the entire treatment process, as well as a high level of optimization of staffing activities on a daily basis", said Benoit Raskin, executive director of Particle Oncology Solutions Integration at Ion Beam Applications (IBA), whose mission is to fight cancer through solutions for cancer diagnosis and therapy.

The center will also be equipped with XiO, a comprehensive system that combines the latest tools and most robust dose calculation algorithms to generate quick, accurate treatment plans. Developed more than a decade ago, XiO for proton therapy is in clinical use at more proton facilities than any other commercial vendor with a similar product.

Raskin says XiO delivers a comprehensive planning functionality that addresses all of IBA's clinical needs. "It will support all proton treatment modalities: Scattered or Wobbled beams, Spot Scanning and Ocular treatment. XiO's powerful automated planning tools reduce planning time and increase clinical efficiency, in even the most demanding environments."

Mosaiq, as well as XiO treatment planning software from Elekta are designed to support different types of radiation systems and modalities, including intensity modulated radiation therapy (IMRT), and image guided radiation therapy (IGRT). This is in keeping with Elekta's long-standing history of supporting multiple vendors and open systems.

Elekta develops sophisticated state of the art tools and treatment planning systems for radiation therapy and radiosurgery, as well as workflow enhancing software systems across the spectrum of cancer care.

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