Deep Brain Stimulation Surgery Approved to be Performed Under General Anesthesia

The Food and Drug Administration (FDA) has granted approval to Medtronic’s Asleep Deep Brain Stimulation (DBS) surgery (Medtronic, Minneapolis, MA) for people with Parkinson disease (PD) as well as for those with essential tremor. Previously, the surgery was approved with a contraindication in labeling meaning that test stimulation could only be performed while the patient was awake. The new approval enables patients to receive the surgery while under general anesthesia (GA).

The approval is based on clinical data demonstrating that people with PD who received the DBS surgery while under GA showed similar improvements in certain motor symptoms compared with those who received the surgery while awake. Surgery conducted under GA was shown to maintain patient safety while potentially improving surgical efficiency and reducing the amount of time required to perform the procedure compared to procedures conducted on a patient who is awake.

“Asleep DBS offers a safe, comfortable and less stressful experience for patients who are apprehensive about the surgery,” said Francisco Ponce, MD, Neurosurgeon and Chief of Stereotactic and Functional Neurosurgery at The Barrow Neurological Institute. “Whether performed asleep or awake, DBS is proven to reduce motor symptoms in movement disorders like Parkinson’s.”

Medtronic's DBS system utilizes the Percept (Medtronic, Minneapolis, MN) family of neurostimulation systems. Percept devices incorporate BrainSense technology to enable the capture and recording of brain signals, providing healthcare providers with valuable data to personalize therapy.