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FDA Approves Medtronic’s Deep Brain Stimulation Technology for Asleep Capabilities
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Medtronic's asleep DBS approval could expand treatment options for patients unable to tolerate awake surgery, enhancing access to deep brain stimulation therapy.
Amaza Reitmeier
Credit: LinkedIn
According to a new announcement, the FDA has granted approval to Medtronic’s deep brain stimulation (DBS) technology to be used while a patient is under general anesthesia, or asleep, in the context of treating Parkinson disease (PD) or essential tremor.1
Typically, the standard established DBS procedure is based on awake surgery with intraoperative microelectrode recording associated with clinical testing to ensure good positioning of the lead; however, this procedure is sometimes perceived as uncomfortable for patients who are unable to tolerate awake surgery with extensive time off their medication. Ultimately, the FDA’s decision to approve Medtronic’s DBS for asleep purposes may provide greater treatment opportunities to a significant portion of potential candidates for surgery.
"This is a significant advancement in our surgical offering, providing another safe and effective option for patients considering DBS." Amaza Reitmeier, vice president and general manager of Brain Modulation, a portion of the NeuroScience Portfolio at Medtronic, said in a statement.1 "This approval underscores our dedication to continuous innovation to address the needs of patients and healthcare providers."
There have been a number of studies evaluating the positive impacts of asleep DBS, including a 2021 phase 2 trial using Medtronic’s intraoperative imaging guidance (O-arm). In the study, leads were implanted in the subthalamic nucleus (STN) according to probabilistic stereotactic coordinates with a surgical robot under O-arm imaging guidance under either general anesthesia without microelectrode recordings (asleep group; n = 20) or local anesthesia with MER and clinical testing (awake group; n = 9).2
Owing to its randomized design, the study supported the hypothesis that motor outcomes after asleep STN-DBS in PD may be noninferior to the standard awake procedure. All told, the mean motor improvement rates on the Unified Parkinson’s Disease Rating Scale Part III between OFF and ON stimulation without medication were 52.3% (95% CI, 45.4%-59.2%) in the asleep group and 47.0% (95% CI, 23.8%-70.2%) in the awake group, 6 months after surgery. Overall, 3 patients (33%) in the awake group and 8 in the asleep group (40%) had at least 1 adverse event potentially linked with neurostimulation.
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"Asleep DBS offers a safe, comfortable and less stressful experience for patients who are apprehensive about the surgery,” Francisco Ponce, MD, a neurosurgeon and chief of stereotactic and functional neurosurgery at The Barrow Neurological Institute, said in a statement.1 "Whether performed asleep or awake, DBS is proven to reduce motor symptoms in movement disorders like Parkinson [disease]."
Since 1987, Medtronic has served over 180,000 patients in more than 70 countries with its DBS therapy. It is one of 3 original DBS system manufacturers, including Abbott (formerly St. Jude Medical) and Boston Scientific. Medtronic Percept, its main DBS technology, includes neurostimulators that transmit electrical signals via slender wires to specific targets affected by debilitating neurological disorders. The Medtronic Percept family of neurostimulators is the first and only DBS system with sensing, directionality, and advanced programming.
Analysis of the literature including retrospective, prospective nonrandomized studies, meta-analyses, and literature reviews suggests that there is no significant difference in motor outcomes between asleep and awake STN-DBS. Asleep surgery may lead to lower overall surgery complication rates, but awake procedure may lead to fewer stimulation-induced adverse events. In addition, asleep DBS may allow for shorter surgery time and more precise electrode placement within 1 millimeter of the target compared with 1-2 millimeters with traditional DBS.
Earlier this year, Medtronic announced the FDA approval of its Percept RC DBS system, adding to the Medtronic Percept family, which includes the Percept PC neurostimulator, BrainSense technology, and SenSight directional leads. Percept RC is the smallest and thinnest dual channel neurostimulator available for DBS. It is equipped with BrainSense technology that captures and records brain signals to provide insights that enable a healthcare provider to adapt and personalize therapy to a patient’s evolving needs. Unlike other rechargeable devices, the Percept RC battery offers at least 15 years of service life with consistent and fast recharge performance.3
