
FDA approves fully asleep DBS surgical procedure by Medtronic
August 13, 2024
The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Asleep Deep Brain Stimulation (DBS) surgery for individuals with Parkinson’s disease or essential tremor.
Amaza Reitmeier, a vice president and general manager for brain modulation at Medtronic, noted this advancement provides a safe and effective surgical option for those considering DBS. DBS involves implanting electrodes in specific brain areas to deliver electrical impulses through a neurostimulator, helping to regulate abnormal brain activity and ease motor symptoms such as involuntary shaking, muscle stiffness, and slowed movements.
Traditionally, DBS requires the patient to be awake during the electrode placement, allowing for real-time feedback, while the second part involving electrode attachment to the stimulator can involve general anesthesia.
Recent advancements have allowed for the entire DBS procedure to be conducted under general anesthesia, shortening surgery time and reducing stress for patients.
Studies have shown that both awake and asleep DBS provide similar relief from motor symptoms, with the latter offering significantly shorter surgery times without compromising efficacy.
Medtronic’s Percept RC DBS system, approved by the FDA earlier this year, features technology that captures brain activity, allowing for personalized therapy adjustments. It boasts a battery that can be recharged in less than an hour and offers at least 15 years of service life, with software updates available without needing device replacement.
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