CE Mark for Rechargeable Deep Brain Stimulator

The CE (Conformite Europeenne) Mark approval has been given to the Brio neurostimulator, the world’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson’s disease. The Brio nuerostimulator is produced by St. Jude Medical, Inc.

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 10mm profile and weighs 29 grams (approximately 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,” says Professor Dr. Volker Sturm, chairman of neurosurgery at the University Hospital of Cologne. “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, Dr. Mohammad Maarouf, 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,” says 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 Brio neurostimulator 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.

The Brio neurostimulator also features:

• Constant current circuitry that automatically adjusts to deliver consistent therapy over time.
• A dual header that accommodates two leads, allowing for bilateral stimulation from one device.
• High power capability, making it an appropriate choice for patients who require high energy settings to control their symptoms.
• A rechargeable battery that can be easily charged through a portable, wireless charging system, allowing patients the freedom to recharge comfortably while doing other activities.
• Additionally, St. Jude Medical has recently received CE Mark approval for the Guardian Burr Hole Cover System, a DBS system component that allows physicians to efficiently secure the electrical leads. The Guardian System is compatible with all St. Jude Medical DBS leads.

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. For more information about these studies, visit www.BROADENstudy.com and www.PowerOverET.com.

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