St. Jude Medical’s (NYSE:STJ) deep brain stimulation implant proved safe and effective in treatment of patients with severe therapy-resistant depression.
Results from the first multi-center pilot study, conducted among 21 patients, found that 62 percent reported a 40 percent reduction in depression symptoms and 29 percent reported that their symptoms were cut in half after one year.
Study subjects received a Libra DBS implant near the collarbone, connected to small leads that deliver mild electrical pulses to an area of the brain called Brodmann Area 25, which is believed to regulate sleep, appetite, mood, anxiety, memory formation and self-esteem.
"The reduction in depression scores is clinically significant as these patients had previously tried multiple medications, psychotherapy and/or electroconvulsive therapy without success," primary investigator and neurosurgeon at Toronto Western Hospital Dr. Andres Lozano said in prepared remarks. "To see 62 percent of the patients in this study respond at one year gives us hope that this research may lead to a therapy for this hard-to-treat patient population."
Before DBS therapy, 70 percent of the enrolled patients were considered "severely or extremely ill" using the Clinical Global Impression of Severity rating scale. After 12 months more than 80 percent of patients showed improvement and none were rated severely or extremely ill, according to St. Jude.
Eight of the patients were able to return to their day-to-day lives and two patients were considered "in remission."
"These findings are significant as they confirm the basis on which we established the Broaden pivotal study," St. Jude Medical neuromodulation division president Rohan Hoare said in a press release. "These results add to the growing evidence suggesting that DBS therapy may help patients who currently don’t have an adequate treatment option in managing severe depression."
The St. Paul, Minn.-based health care giant’s Broaden study has FDA approval under an investigational device exemption to study stimulation in Brodmann Area 25 to determine whether it is a safe and effective treatment for severe depression. The FDA in July gave the study the green light to expand to 20 sites across the U.S. and 125 patients.
St. Jude won CE Mark approval for its Athena deep brain stimulation programmer, designed to help physicians control the amount of current delivered to patients’ brains to treat Parkinson’s disease, in September 2010. The company landed Australian approval for that device in January 2011.
Boston Scientific Corp. (NYSE:BSX) is also deep into the neurostimulation and neuromodulation business, developing products for the treatment of hemorrhagic stroke, intracranial athero disease, and acute ischemic stroke. Medtronic Inc. (NYSE:MDT) launched its Activa device for the treatment of Parkinson’s disease earlier this year, after winning CE Mark approval in the European Union for it’s deep-brain stimulator for treatment of epilepsy last fall.
