Medtronic
Medtronic plc has received U.S. Food and Drug Administration (FDA) approval of Asleep Deep Brain Stimulation (DBS) surgery for people with Parkinson’s and people with essential tremor. Medtronic says it is the first and only company to receive FDA approval to offer DBS surgery while a patient is asleep under general anaesthesia, or awake.
“This is a significant advancement in our surgical offering, providing another safe and effective option for patients considering DBS,” said Amaza Reitmeier, Vice President and General Manager, Brain Modulation within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “This approval underscores our dedication to continuous innovation to address the needs of patients and healthcare providers.”
Several studies have published safety and efficacy data on Asleep DBS and compared the two different DBS modalities: Asleep DBS and Awake DBS. The company says the clinical data confirms people with Parkinson’s Disease achieve a comparable improvement in certain motor symptoms whether having Asleep DBS or Awake DBS surgery.
According to Medtronic, recent studies also show Asleep DBS procedures maintain patient safety and may foster surgery efficiencies, shortening procedure time compared to Awake DBS.
“Asleep DBS offers a safe, comfortable and less stressful experience for patients who are apprehensive about the surgery,” said Francisco Ponce, M.D., 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.”
DBS uses a surgically implanted medical device, similar to a cardiac pacemaker. Medtronic Percept neurostimulators, which received FDA approval in early 2024, transmit electrical signals through slender wires to specific brain targets affected by debilitating neurological disorders. Medtronic says its Percept family of neurostimulators is the first and only DBS system with sensing, directionality, and advanced programming.
Medtronic’s DBS system with BrainSense technology captures and records brain signals, equipping healthcare providers with data and insights used to tailor therapy to patients’ individual needs.
