St. Jude's directional deep-brain stimulation gets FDA OK

St. Jude Infinity DBs apps on iPad and iPod touch, implantable stimulators in two sizes, battery system and directional leads--Courtesy of St. Jude Medical

The FDA approved St. Jude Medical’s deep-brain stimulation device and its directional leads. The first directional leads to earn the FDA nod, they allow the device to target specific areas in the brain to ease Parkinson’s and essential tremor symptoms.

There is no cure for dystonia, Parkinson’s or essential tremor, so treatments such as DBS seek to ease symptoms and improve quality of life. The St. Jude Medical Infinity DBS system seeks to reduce movement disorder symptoms by sending mild pulses of electric current to the brain from a stimulator implanted in the body. The directional leads allow the doctor to divert current away from parts of the brain where it would cause side effects, said Dr. Kelly Foote, professor of neurosurgery and co-director of the University of Florida Center for Movement Disorders, in a statement. This differentiates it from traditional DBS therapy, which cannot direct current in a specific direction.

In addition to the stimulator and leads, the system includes a long-lasting, recharge-free battery and a wireless iOS app that communicates with the implant via Bluetooth, according to the statement. Neurologists use the app on an iPad mini to program stimulation, while patients manage their symptoms and treatment using a digital patient controller on an iPod touch.

“The new St. Jude Medical Infinity system was designed to streamline therapy programming, allowing physicians more time to provide care to more patients,” said Dr. Allen Burton, St. Jude’s medical director of neuromodulation and vice president of medical affairs, in the statement. “The system was also designed to provide patients with the best possible experience to manage their symptoms in a discreet manner that fits more easily into their lives.”

St. Jude publicized the system’s launch in the same announcement. It joins the FDA-approved Brio Neurostimulator System to treat Parkinson’s and essential tremor symptoms, which is implanted just under the skin of the upper chest. Medtronic markets the competing Activa system to treat Parkinson's symptoms. St. Jude also markets the Libra DBS device in Europe for the treatment of dystonia, a movement disorder that causes muscles to involuntarily contract and spasm.