Medtronic announced that the company received CE Mark approval for Reclaim Deep Brain Stimulation (DBS) Therapy to address the treatment of chronic, severe treatment-resistant obsessive-compulsive disorder (OCD). Deep brain stimulation therapy has gained approval for the first time in Europe for the treatment of a psychiatric disorder.
The company will conduct a multi-national post-market study to commence in at least eight sites in Europe following CE Mark approval. Apart from following any adverse events associated with the therapy, the study will further evaluate improvements seen in OCD symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), before deep brain stimulation to 12 months after.
Professor Loes Gabriels from the Catholic University of Leuven, Belgium, and lead investigator of the post-market study comments: For patients with severe OCD who have tried and failed treatment through the treatment algorithm, DBS could result in a significant improvement of a disease that severely impacts on their lives. This study will be important in reinforcing the evidence base of DBS in the treatment of psychiatric conditions.
Prof Nuttin, neurosurgeon at the Catholic University of Leuven in Belgium comments: It is clear that for the best results a multidisciplinary team consisting of a psychiatrist and neurosurgeon plus several other important specialties must be involved when selecting, treating and managing the long-term follow-up for a patient who undergoes deep brain stimulation for OCD.
Neurostimulators used for Reclaim DBS Therapy are same as those used to treat common movement disorders like dystonia and Parkinson’s disease. However, as the area of the brain targeted for OCD is different, the company has designed special unique DBS lead.
Deep brain stimulation therapies were pioneered by Medtronic neuromodulation and to date, with more than 20 years of experience, 60,000 people worldwide have benefited from Medtronic DBS therapy for Parkinson’s disease, essential tremor and dystonia, said Karl Schweitzer, vice president for Medtronic’s Neuromodulation business in Europe. This approval marks the world’s first steps into DBS for Psychiatric disorders and demonstrates how Medtronic continues to lead the way in research, therapy indication expansion, and technology.