St. Jude Gets FDA OK to Broaden Deep Brain Stimulation Study for Depression

St. Jude announces plans to expand depression treatment study.

<!– /* Font Definitions */ @font-face {font-family:"MS 明朝"; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:"MS 明朝"; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-520092929 1073786111 9 0 415 0;} @font-face {font-family:Cambria; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1073743103 0 0 415 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"MS 明朝"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"MS 明朝"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;} @page WordSection1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} -St. Jude Medical Inc. has received U.S. Food & Drug Administration approval to expand its Broaden study of deep-brain stimulation for major depressive disorders. The controlled, blinded study of the Libra deep brain stimulation system will enroll up to 124 patients in as many as 20 sites across the United States.

“We are committed to leading this research in hopes of finding a solution for people who currently don’t have a treatment option,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “By expanding the Broaden study, we are able to continue to add to the body of evidence that will determine if deep brain stimulation is indeed an option for managing major depressive disorder.”

The Libra system sends mild electrical pulses to a specific target in the brain from a device implanted in the chest. The study will examine whether stimulating an area of the brain known as Brodmann Area 25 is safe and effective. Prior to the expansion, this study was conducted in Chicago, Ill., New York, N.Y., and Dallas, Texas. Participants must be classified as having treatment-resistant depression and must have failed multiple treatments to be a candidate for the study.

Keep Up With Our Content. Subscribe To Medical Product Outsourcing Newsletters