St. Jude, the company which acquired Advanced Neuromodulation Systems in 2005, is going ahed with a pivotal trial of Deep Brain Stimulation for Major Depression to seek PMA from the Federal Drug Administration (FDA). The FDA has granted what is known as an investigational device exemption that clears St. Jude to begin enrollment for the trial which is named BROADEN (BROdman Area 25 DEp brain Neurostimulation). The stimulation site is cg25; up to now patient numbers and study sites are kept confidential.You can read more on this study here:
- CNNMoney.com
- PR-inside.com (an Austrian Press Service)
