Posted by phillybob on April 13, 2001, at 23:33:58
In reply to Re: I'd be wary because.... » PhoenixGirl, posted by sweetmarie on April 12, 2001, at 10:38:36
Implantable Device Approved in Canada for Treatment of Depression
--------------------------------------------------------------------------------WASHINGTON (Reuters Health) Apr 11 - Cyberonics Inc. said Wednesday that it has received approval in Canada to market its NeuroCybernetic Prosthesis, an implantable device for the treatment of depression and bipolar disorder.
The system, similar to a cardiac pacemaker, is implanted beneath the collarbone and continuously delivers intermittent electrical pulses to the vagus nerve. The US Food and Drug Administration approved the device in July 1997 as adjunct therapy for patients over the age of 12 with refractory partial onset seizures.
Health Canada approved the device to treat "chronic or recurrent depression in patients that are in a treatment resistant or treatment intolerant major depressive episode," Cyberonics said in a news release. The Canadian approval mirrors the device's recent CE Mark approval, the company noted.
Both clearances were based on a study in which 1-year follow-up data from 30 patients showed that 46% experienced at least 50% improvement in their depressive symptoms, while 29% reported no remaining symptoms.
The follow-up findings also demonstrated that 91% of subjects who had responded to treatment by the end of the study maintained their response over 1 year, while 18% of patients who were unresponsive at the close of the study had begun to respond to therapy at 1 year.
Separately on Wednesday, Cyberonics issued a statement responding to a warning letter it received in March from the FDA, in which the agency charged the company with delaying for approximately 3 years reports on certain adverse events, including deaths, in patients with epilepsy implanted with the device. The company noted a number of procedural and staff changes it had made to improve its reporting system.
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URL: http://www.dr-bob.org/babble/20010411/msgs/59763.html