March 13, 2010 / 1:22 AM / 9 years ago

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) 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)

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