Medtronic received FDA approval for asleep DBS surgery: A new choice for Parkinson disease treatment

In August 2024, Medtronic, the major maker of DBS neurostimulator, received FDA approval for deep brain stimulation (DBS) surgery under general anaesthesia where the patient is fully asleep. Previously, patients had the surgery under partial sedation.

Awake or Asleep DBS Surgery?

DBS has transformed the lives of many patients with Parkinson disease, helping them regain control over movement and independence. However, for some, the idea of undergoing brain surgery while awake can be daunting. Now, with the FDA approval, patients can opt to have DBS surgery while fully asleep, ensuring comfort without sacrificing treatment effectiveness.

CALM: Benefits of Asleep DBS

C – Comfort: Sleep through the procedure with reduced anxiety.

A - Additional Choice: Empower yourself with the option to choose asleep or awake

L - Less Stress: Reduce anxiety and emotional strain during surgery

M - More Suitable for Some Patients: Ideal for patients who may find it hard to tolerate procedure awake or under partial sedation.

Choosing Between Awake and Asleep DBS

Discuss both techniques with your neurosurgeon to ensure the best possible outcome.

Restoring Hope

DBS continues to improve motor and non-motor symptoms, reducing the need for medications and enhancing quality of life. This additional choice allows patients to regain control of their treatment and future, offering hope and inproved quality of life ahead.

Dr Nicolas Kon, neurosurgeon specialising in DBS surgery, remarked, “Asleep DBS has now received regulatory approval in the US. This further establishes that whether performed asleep or awake, DBS is proven to help relieve the symptoms of Parkinson disease.”

References

1. Medtronic receives landmark FDA approval for asleep deep brain stimulation surgery. News release. Medtronic. August 12, 2024. Accessed August 12, 2024. https://news.medtronic.com/2024-08-12-Medtronic-receives-landmark-FDA-approval-for-Asleep-Deep-Brain-Stimulation-surgery
2. Engelhardt J, Caire F, Damon-Perriere N, et al. A phase 2 randomized trial of asleep versus awake subthalamic nucleus deep brain stimulation for Parkinson’s disease. Stereotact Funct Neurosurg. 2021;99(3):230-240. doi:10.1159/000511424
3. Read more about deep brain stimulation surgery and Parkinson disease