FDA panel narrowly clears Medtronic DBS device

March 15, 2010 by MedCity News

By Thomas Lee

A Food & Drug Administration panel narrowly approved a deep brain stimulation device developed by Medtronic Inc. (NYSE:MDT) to treat epilepsy.

The panel voted 7-5 to green-light the Activa DBS, which uses electricity to stimulate the anterior nucleus region of the brain. The panel’s findings are not binding on the FDA, but the agency almost always follows the recommendations of such bodies.

The close vote reflected some unease with the therapy. The FDA released documents March 10 indicating that a Medtronic study failed to demonstrate that patients using the device experienced less seizures than patients in a control group.

The agency also noted patients reporting new or worsening anxiety, depression and memory loss were more active in the therapy group than the control group. One patient committed suicide and six others were reported as suicidal. One patient committed suicide and six others were reported as suicidal. The FDA also noted the deaths of three patients from Sudden Unexpected Death in Epilepsy.

The panel’s approval comes with conditions: Medtronic must perform a post-approval study to meet long-term follow-up and labeling requirements.

Permalink