A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported the first patient was implanted in a clinical study that is investigating whether deep brain stimulation (DBS) therapy will help people who suffer from major depressive disorder, a severe form of depression. The patients were implanted with the St. Jude Medical Libra DBS system.
The study, called BROADEN (BROdmann Area 25 DEep brain Neuromodulation), is evaluating the safety and effectiveness of DBS in patients with depression for whom currently available treatments are not effective.
This study is researching a specific area in the brain called Brodmann Area 25 that is thought to be involved in depression.
St. Jude Medical owns the intellectual property rights, and has various patents issued and pending, for the use of neurostimulation at Brodmann Area 25. The Libra DBS provides mild pulses of current from a device implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain.
"This depression study represents a continuation of our commitment to provide solutions for those who are suffering and in need of additional therapy options," said Chris Chavez, president of the St. Jude Medical Advanced Neuromodulation Systems (ANS) division. "The Brodmann Area 25 study is an important step in bringing physicians and their patients a neuromodulation therapy that, if successful, will treat this debilitating form of depression."
The ANS division of St. Jude makes implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders.