UPDATE 2-US FDA panel backs Medtronic implant for epilepsy

* Panel votes 7-5 to recommend approval with conditions

* FDA will consider panel's advice
(Adds panel member, Medtronic quotes)

By Lisa Richwine

GAITHERSBURG, Md., March 12 (Reuters) - An implanted
Medtronic Inc (MDT.N: Quote, Profile, Research) brain device should be approved for
treating epilepsy patients, a U.S. advisory panel said in a
close vote on Friday.

The Food and Drug Administration advisory panel voted 7-5
to recommend approval of the Deep Brain Stimulation (DBS)
therapy for epilepsy patients who cannot control their seizures
with medication.

"I believe this is a safe and effective device for a very
intractable patient population," said Dr. Mercedes Jacobson, a
panelist from Temple University School of Medicine.

The device already is sold for treating Parkinson's disease
and other disorders.

The FDA will consider the recommendation. The agency
usually approves products backed by advisory panels.

Wider FDA approval could help Medtronic expand sales of the
device. The product is part of the company's neuromodulation
business, which made up about $1.4 billion of its nearly $15
billion in fiscal 2009 sales.

About 2.3 million adults in the United States have been
diagnosed with epilepsy, a brain disorder that causes seizures.
About 430,000 still have seizures while taking anti-epilepsy
medications or suffer intolerable side effects, Medtronic
said.

Those patients need new treatments as frequent seizures can
be devastating, the company told the panel.

With DBS therapy, surgeons implant a generator in the chest
to send electrical pulses to electrodes that target specific
areas deep inside the brain.

In Medtronic's study, 110 patients had the device implanted
but it was only turned on in half. The patients also took
epilepsy drugs. Before the trial, they had about 20 seizures
per month.

FDA reviewers said the study missed its main goal of
showing the device reduced seizures more over three months than
no electrical stimulation.

Medtronic proposed removing results from one patient with a
far higher number of seizures. By removing that result,
seizures were reduced by 5.4 per month with treatment, FDA
reviewers said. The reduction was 2.9 per month for others in
the control group.

Some panelists were not convinced that Medtronic's data
showed a meaningful benefit.

"We're unsure about efficacy for three months in a chronic
condition," said Dr. Bernard Ravina, a panelist from University
of Rochester Medical Center.

The panel urged the FDA to require warnings about problems
such as suicidal behavior and depression seen in some patients
in Medtronic's study. Seven patients who had the device turned
on reported suicidal thoughts or actions, the FDA said.
Medtronic had reported that one patient committed suicide. His
device had been turned on but it had stopped working three
weeks earlier when the battery ran out.

The committee urged follow-up studies to see how patients
fared for up to five years with the implant.

Tom Tefft, president of Medtronic's neuromodulation
business, said the company was pleased with the panel decision
and Medtronic hopes for a final ruling this year.

"We feel very confident with the clinical outcomes and the
benefits of the therapy," Tefft told reporters.

The current cost for the device, surgery and hospital
expenses is about $60,000, Medtronic spokeswoman Cindy Resman
said. She said she could not say what the cost would be for
epilepsy patients.
(Reporting by Lisa Richwine)