FDA OKs Brain Stimulator for Depression

[Guest guest]

Something new every day folks:

 

[from news]

 

By LAURAN NEERGAARD, AP Medical Writer

Sat Jul 16,10:56 AM ET

 

 

The government on Friday approved a new therapy for the severely

depressed who have run out of treatment options: a pacemaker-like

implant that sends tiny electric shocks to the brain.

 

The Food and Drug Administration's clearance opens Cyberonics Inc.'s

vagus nerve stimulator, or VNS, as a potential treatment for an

estimated 4 million Americans with hard-to-treat depression — despite

controversy over whether it's really been proven to work.

 

" These are patients pretty much at the end of the line in terms of

what treatment options are available to them, " said FDA medical

device chief Dr. Daniel Schultz, who said he personally was persuaded

by Cyberonics' research despite initial skepticism within his agency.

 

The pacemaker-like implant has been sold since 1997 to control

intractable epilepsy, a much smaller market.

 

A generator the size of a pocket watch is implanted into the chest.

Wires snake up the neck to the vagus nerve, delivering tiny electric

shocks through that nerve and into a region of the brain thought to

play a role in mood.

 

Cyberonics began a 200-patient study to see whether VNS could treat

depression patients not adequately helped by other therapies. An FDA

review last year found no difference after three months of implant

treatment. Cyberonics argued that a year later, a significant number

of the VNS recipients had had their depression ease.

 

That yearlong follow-up hadn't been done according to standard

scientific procedures — it wasn't a randomized controlled study — and

thus critics questioned its validity.

 

Cyberonics continued to track the VNS recipients, and two years later

a third of patients in the original study had experienced some

response and between 17 percent and 20 percent were in remission,

Schultz said, evidence he ultimately found persuasive.

 

Still, critics have complained that without a comparison group, it's

unclear if the implant really helped or the depression eased for some

other reason.

 

Schultz said there are some safety warnings. The chief risk: More

than half of patients in the depression study experienced at least

temporary voice alterations — a hoarseness or raspiness, or

voice " breaks " — that seem to persist in a significant number, he

said.

 

Other complications include difficulty breathing or swallowing, he

said. Deaths have been reported among some epilepsy patients who have

a VNS implant, but Schultz said there was no sign of increased deaths

in the depression study.

 

___

 

On the Net:

 

Cyberonics: http://www.vnstherapy.com