Title: CYBX to give away depression device in study
Birdbomb - January 29, 2007 07:35 AM (GMT)
Cyberonics to give away depression device in study
Source
By Susan Heavey
GAITHERSBURG, Md., Jan 26 (Reuters) - Cyberonics Inc. (CYBX.O: Quote, Profile , Research) will offer its VNS Therapy depression-treatment device for free to enroll more patients in a government-mandated study, the company told a U.S. Food and Drug Administration advisory panel on Friday.
The FDA had requested ongoing trials as a condition of the implanted device's 2005 approval for treatment-resistant depression, including a study on dosing as well as a patient registry.
Critics, including a senior U.S. senator, had questioned whether there was enough data to warrant FDA approval in the first place. Iowa Republican Sen. Charles Grassley has also investigated the agency's handling of the approval.
The stopwatch-sized device, which is permanently implanted in the chest, aims to curb feelings of hopelessness and other problems that accompany depression by sending impulses to the brain through a nerve in the neck. It has already been approved to treat epilepsy.
Despite the FDA's approval, doctors and health insurers have remained skeptical.
Cyberonics' Dr. Richard Rudolph told an FDA advisory panel that the company would give away the device to help enroll more patients by its January 2008 deadline for the dosing study. It will also offer participating surgeons a negotiated rate, he said.
The average cost for a patient to receive the device and accompanying surgery is $25,000, a company spokeswoman said. About 460 patients are needed for the study, and 89 have enrolled as of Dec. 31.
"We had some concerns about the ability to maintain that schedule in light of a suboptimal payer environment," Rudolph, the company's chief medical officer, told Reuters before addressing the panel.
The study is on schedule now, but Cyberonics had not expected the current situation in which most insurers cover the device on a case-by-case basis, he added.
Rudolph said initial data from the registry's first three months supported VNS Therapy's approval for depression.
The FDA called on its panel of outside advisors for an update on the device maker's progress in gathering follow-up data.
An FDA staff medical officer earlier said the study was proceeding on time but that concerns remained, including cost and reimbursement issues.
Panelists were also asked to offer advice on a possible VNS Therapy competitor -- privately held Neuronetics's experimental NeuroStar TMS Therapy.
The group questioned whether the company's data proved NeuroStar worked but appeared to have few safety concerns. They did not take a formal vote on whether the FDA should approve it. The agency usually follows the advice of its advisers. Rocking4Epilepsy - February 1, 2007 07:13 PM (GMT)
Well I was always told....
If ya can't sell it GIVE it away just to get rid of it... :)
Rocking4Epilepsy - February 2, 2007 05:36 PM (GMT)
I have been thinking and hopefully Glenablom will reply seeing she seems to have an 'in" with the company....
Its great they are willing to GIVE these devices away but a few questions have come to my mind.....
Is this device under warrenty?
Do they have a device to let doctors know the battery is dying?
Does this mean the CYBX rep has unlimited access to your medical files?
I have a few more questions but I will let you reply to these first.
hugs
labrat - February 3, 2007 02:51 PM (GMT)
I can answer two of your questions:
1.) NO, there is no warranty
2.) NO, they are working on something, but at this time there is nothing to let the doctor or patient know that the battery is about dead.
I'll leave the others for Birdbomb.
Labrat :im_033:
Rocking4Epilepsy - February 7, 2007 02:13 PM (GMT)
Thanks Tamera,
Anyone else have imput on this?
Glenna, Are you still wtih us?
I would love to hear your thoughts seeing you are dealing with this device ona good note...
labrat - December 20, 2007 12:47 AM (GMT)
I have 4 friends, that use the same psychiatrist I use, and they were in the test group. At first they were set to go on once an hour. That wasn't working too well. I'm guessing that after a while Cyberonics let the doctors loose, after about six months. I am seeing improvement on all four of them now that our Dr, has control of settting it.