Medtronic deep brain stimulation software earns FDA nod

Activa RC neurostimulatior for deep brain stimulation--Courtesy of Medtronic

The FDA cleared Medtronic’s StealthStation software to help in the planning and placement of leads for deep brain stimulation, the company announced Monday.

In Medtronic’s deep brain stimulation therapy, a small neurostimulator is implanted under the skin of the chest. The stimulation is delivered via leads that are implanted in the brain and connected to the implant. A clinician uses an external programmer to set and adjust the stimulation.

The StealthStation Cranial Software is integrated with Medtronic’s O-arm imaging system in a solution that offers preoperative planning and intraoperative imaging for lead placement procedures, the company said in a statement.

"The new StealthStation software works seamlessly with O-arm to give me a single solution for pre-operative planning and real-time 3D imaging of the brain in the OR, and that streamlines my workflow for DBS lead placement," said Dr. Jonathan Carlson, a neurosurgeon at Providence Spokane Neuroscience Institute, in the statement.

More than 140,000 patients worldwide have received a Medtronic DBS neurostimulator. The treatment targets specific symptoms by delivering mild electrical stimulation to the brain. It is used to ease symptoms of essential tremor, Parkinson’s disease and dystonia.

In August, Medtronic’s SureTune 2 software for DBS therapy scored a CE mark. It offers physicians patient-specific visualizations to help them “tune,” or choose the most appropriate settings for, a patient’s stimulation.