Medtronic has received US Food and Drug Administration (FDA) approval of asleep deep brain stimulation (DBS) surgery for people with Parkinson’s disease and people with essential tremor. Medtronic claims that, in the process, it has become the first and only company to receive US FDA approval to offer DBS surgery while a patient is either 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.
According to Medtronic, clinical data confirm that people with Parkinson’s disease achieve a comparable improvement in certain motor symptoms whether having asleep or awake DBS surgery. Recent studies also show asleep DBS procedures maintain patient safety and may foster surgical efficiencies, shortening procedure time compared to awake DBS, the company further states.
“Asleep DBS offers a safe, comfortable and less stressful experience for patients who are apprehensive about the surgery,” said Francisco Ponce (Barrow Neurological Institute, Phoenix, USA). “Whether performed asleep or awake, DBS is proven to reduce motor symptoms in movement disorders like Parkinson’s.”
Medtronic’s Percept neurostimulators—the company’s line of implantable DBS systems—transmit electrical signals via slender wires to specific brain targets affected by debilitating neurological disorders. The Percept family of neurostimulators is the first and only DBS system with sensing, directionality, and advanced programming, the company claims, also noting that its accompanying BrainSense technology captures and records brain signals to equip healthcare providers with valuable data and insights needed to tailor therapy to patients’ individual needs.
