Taking the Measure

St. Jude Medical has announced CE (Conformité Européenne) Mark approval for its the Brio neurostimulator, which the company calls the world’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson’s disease. St. Jude Medical makes a variety of implantable medical products, including the Eon Mini rechargeable spinal-cord stimulator that treats chronic pain of the trunk and limbs as well as pain from failed back surgery. I had the opportunity to visit St. Jude Medical's Dallas facility last December to interview test engineer Eddie Abshire, winner of our 2009 Test Engineer of the Year award. You can read about Eddie and his work here, and you can nominate a candidate for the 2010 Test Engineer of the Year here.

In conjunction with the latest news from St. Jude Medical, the company announced that 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 g (approximately 1 oz). St. Jude Medical says the device has the greatest recommended implant depth of any rechargeable DBS device.

"Deep brain stimulation therapy is often the preferred treatment for many Parkinson’s disease patients," said 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 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."

The Brio neurostimulator also features
• a 10-year battery longevity approval;
• 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; and
• a rechargeable battery that can be easily charged through a portable, wireless charging system.

In addition, St. Jude Medical announced it 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 company also said it is also currently developing new DBS applications to address a growing list of neurological and psychiatric disorders. Clinical studies are underway in the US for depression and essential tremor. For more information about these studies, you can visit www.BROADENstudy.com and www.PowerOverET.com.