Intercept Epilepsy Control System

Elisa

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It is a lot like a VNS, but the difference is the leeds go right to the brain, and not a nerve that goes to the brain.
 

Bernard

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It kind of makes you wonder just how far away we are from the wireheads envisioned by Larry Niven in his book, The Ringworld Engineers:
Larry Niven said:
It wasn't just the happy smile that fooled them. It was the fist-sized droud that protruded like a black plastic canker from the crown of Louis Wu's head. They were dealing with a current addict, and they knew what to expect. For years the man must have had no thought but for the wire trickling current into the pleasure center of his brain. He would be near starvation from self-neglect.
 

Bernard

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Medtronic, Inc. (NYSE:MDT - News), today announced that it has entered into a patent cross-licensing agreement with NeuroPace, Inc., a privately held medical device company specializing in the detection, treatment and monitoring of epilepsy and other neurological disorders via responsive brain stimulation. Under the terms of the royalty-bearing, non-exclusive agreement, the two companies cross-licensed patents and patent applications of neurological technology related to direct electrical stimulation or monitoring of the brain. Specific terms of the agreement were not disclosed.

...

Medtronic currently is conducting a pivotal clinical trial in the United States for the Intercept(TM) Epilepsy Control System, the company's brain stimulation therapy that may reduce seizure rates in patients with epilepsy. NeuroPace also is sponsoring an investigational study with its Responsive Neurostimulator (RNS(TM)) system. ...
Medtronic and NeuroPace Cross License Patents for Treating Neurological Disorders
 

Birdbomb

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Whoaaa--oooo take the money and run.....


Looks like CYBX is gonna take it in the anus on this one. The surgery may be more invasive, deep brain and all, but the criteria of acceptance FOR this treatment will be better defined. Not like the wonderful Holy Grail salemens, we have come to know and love.

IMO this is the devise that will be the undoing of CYBX. For a whole lotta reasons.
 

Bernard

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Looks like Medtronic is working on a less invasive device:
Engineers from Medtronic disclosed a novel amplifier that is a key component in an implantable "brain radio" the company is developing to monitor and control nervous disorders. Overcoming noise generated from today's standard semiconductor processes was one of the biggest hurdles, according to a paper presented at the International Solid State Circuits Conference here Tuesday (Feb. 13).
Medtronic discloses component for "brain radio"
 
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It's nice to see that things such as this new device are being worked on out there in the medical field. I have a friend in Boston whose son just had the NeuroPace device implanted back in August 2006 and he is doing wonderful. Funny how things have changed since I had my brain surgery done over 12 years ago. That was the only choice I had back then. Just look at what choices are out there today...VNS, Gamma Knife, and the NeuroPace device, along with about 4 or 5 new medications that are available.

So much has changed since my surgery. Patients are spending little or no time in ICU and are being sent home far faster than I was. I spent almost three days in ICU and then another 5 days in a regular room. I came home just two days before Christmas.

I'm almost scared to think what kind of devices or procedures they will come up with in the next decade.
 

Birdbomb

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What would be ideal is a cure for epilepsy instead of just treating the symptoms.

All these devises come as just a temporary fix. No one knows the long term effects on the body and some of the side effects are just horrible. But some people have had great successes with them too.
 

brain

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I've been reading up about Neuropace, and seems to be
quite "pushy" around all over the 'net world, stating they're
better than VNS, and some of them are "brassy" to even
to publish all the lawsuits and problems that VNS has/had,
even where you can't "turn it on or turn it off" ...

And some of them are getting pretty bold in their advertising
where they're comparing VNS -vs- Neuropace ....

I can't see how - because they're 2 absolutely different things.

TO ME PERSONALLY:

It's like comparing a garbage disposal system and a built-in
dishwasher in your kitchen sink!

HONEST!


OK OK BIRDBOMB --- you can stop cracking up!
(I sure hope she had depends on!)
 

Birdbomb

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I like your analogy, bet I can guess which one is the garbage disposal. LOL!

:lol:
 

Bernard

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Medtronic announces some news for their deep brain stimulation (DBS) device. I assume they are referring to the Intercept device (now called the "Medtronic DBS Therapy for epilepsy"?):
Data From Pivotal Study Show Medtronic Deep Brain Stimulation Therapy Reduced Seizure Rate in Patients With Severe Epilepsy

Medtronic to Pursue Premarket Approval of Deep Brain Stimulation Therapy for Epilepsy

MINNEAPOLIS – Dec. 8, 2008 – In a clinical trial supported by Medtronic, Inc. (NYSE: MDT), deep brain stimulation (DBS) significantly reduced seizure frequency among patients with medically refractory epilepsy with partial-onset seizures, a form of the neurological condition that does not respond well to antiepileptic drugs. The study, known as SANTE® (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy), is the only prospective, randomized, double-blind pivotal study to evaluate the use of Medtronic DBS for epilepsy. The findings were presented at the American Epilepsy Society (AES) Annual Meeting in Seattle by Robert Fisher, M.D., professor of neurology and director of Stanford Epilepsy Center and principal investigator for the SANTE study.

The results from the SANTE study showed that stimulating the left and right anterior nucleus of the thalamus – the brain’s central message and relay station – with Medtronic’s DBS therapy for epilepsy in conjunction with epilepsy medications produced a statistically significant median percent reduction in seizures compared to a no stimulation control group at the end of the blinded phase of the study (38 percent in the treatment groups vs. 14.5 percent in the control group with both groups continuing on their epilepsy medications without change during this phase). The results from long-term follow up during the trial show even greater reductions in seizures for the majority of patients. Key data highlights:
  • Of the 87 study participants who completed the diaries through month 13, 40 percent experienced a 50 percent or greater reduction in their baseline rate of seizures 13 months after implant.
  • Of the 86 study participants who had at least three months of data from long-term follow up, 60 percent experienced a 50 percent or greater reduction in their baseline rate of seizures. These long-term follow up results represent outcomes from the last three months of available data for each patient (ranged from 12 to 49 months after implant with median follow up of 31 months).
  • During this same long-term follow-up period (last three months of data for each patient), median seizure frequency was reduced by approximately two-thirds, nine percent of study participants had no seizures and 19 percent experienced a greater than 90 percent reduction in seizure frequency.
“Approximately one-third of patients with epilepsy have uncontrollable seizures with little or no response to medications, surgery or other treatments, which has a significant impact on their quality of life,” said Dr. Fisher. “Based on the seizure frequency results from the SANTE study, DBS may become a promising treatment option for appropriate patients.”

The types of adverse events reported in the study were consistent with known adverse events associated with epilepsy and implanted DBS systems. There were no serious unanticipated device-related adverse events. Twenty-two percent of the total reported events were related to stimulation, hardware or procedure and three percent of all adverse events were serious device-related effects. The infection rate was 10.9 percent and the rate of asymptomatic intracranial hemorrhage was 1.3 percent per lead implant. While there was a significantly higher incidence of spontaneously self-reported depression, memory impairment, and anxiety in the active group compared to the control group during the blinded phase, most events resolved spontaneously or with changes in medication or stimulation parameters. Objective neuropsychological assessment at the end of the Blinded Phase did not confirm any statistical differences between the active and control groups.

Patients in the study have had epilepsy for an average of 22 years and 54 percent of the 110 implanted patients had previously undergone resective surgery and/or vagal nerve stimulation therapy. Benefit also was seen in patients with prior history of vagal nerve stimulation or previous epilepsy surgery. The study is still ongoing with some patients having received DBS therapy for more than four years.

About SANTE
The study collected data from 110 patients from 17 U.S. centers who were implanted with a DBS system and were monitored for a minimum of 13 months following implant. Study participants had partial-onset epilepsy, had failed to see benefit from at least three antiepileptic drugs and had an average of six or more seizures per month. All patients continued to receive epilepsy medications while participating in the study. Patients in the study’s active stimulation group received neurostimulation and were monitored for a reduction in seizure rates compared to the control group, who received a DBS implant but received no neurostimulation during the three-month double-blind phase. After the three-month, double-blind phase, all patients received neurostimulation within pre-defined parameters (physicians could choose to make one adjustment to a specified voltage OR frequency at two specified time points) for nine months, followed by a long-term follow up phase where they continued to receive neurostimulation and physicians were allowed to change stimulation parameters. Long-term results reported at the AES meeting represented the results from the last three months of available data for each patient, some of whom have remained on the study for more than four years (range from 13 to 49 months).

Based on the results of this study, Medtronic plans to submit a premarket approval (PMA) application to the U.S. Food & Drug Administration (FDA) seeking approval for Medtronic DBS Therapy for epilepsy.

“We are very encouraged by the SANTE trial results, which demonstrated a positive response with DBS in patients who have had very severe epilepsy for an average of 22 years,” said Rick Kuntz, M.D., president of the Neuromodulation business and senior vice president at Medtronic. “This study reinforces our commitment to exploring other applications for DBS. In this case, we believe these data show promise for patients who have not been able to achieve adequate control of their seizures with medications.”

Other Medtronic neurostimulation therapies already have won significant medical acceptance for the management of symptoms of advanced Parkinson’s disease, essential tremor, and chronic back and leg pain. Medtronic, in collaboration with leading physicians from around the world, has pioneered the use of neurostimulation for treatment of these conditions and has extended its reach into the application of epilepsy.
Press Release
 

brain

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And to imply I must say....

Bernard - I read that, and that was my assumption
of what they were in reference to, but wasn't sure,
I was left with ...

:huh:

To me personally, it doesn't provide too much information
there to prove any sufficient conclusive findings or reports.
Just only the basics. But that of course is a "journalistic"
report so some things could have been "edited" out. I am
unsure, or it could have been held back.

I am confused between the RNS and DBS. They both
sound so much the same and similarity, so I have not a
slightest clue of which end is which?

Am I making sense here?

Therefore I am left with a huge
:?:
over my head ....
 

Bernard

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I am confused between the RNS and DBS. They both
sound so much the same and similarity, so I have not a
slightest clue of which end is which?
They appear to be very similar (to the point where the companies are sharing technology [cross-licensing patents]), but I think the Medtronic DBS system inserts the stimulation leads into the brain while the NeuroPace RNS system has stimulation leads that lay on the surface of the brain.
 
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Not a good sign

Medtronic announces some news for their deep brain stimulation (DBS) device. I assume they are referring to the Intercept device (now called the "Medtronic DBS Therapy for epilepsy"?):
I must say that I am kind of perplex here. This bit of new has all the hallmarks of a re branding operation. It gives you the impression that the product has a long successful history but does not give you factual details, as Brain as pointed out.

I have done some proof reading on a similar piece of press release the other week, for a friend who is doing branding and had to work on a software that is going into a second life try out.

That is not, for me, a good sign coming from a tool that you actually have inserted into your brain...

To be followed.

Cheers,
 

BIGMAN131307

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UPDATE: Medtronic: Device Helps Epilepsy Patients In Study

UPDATE: Medtronic: Device Helps Epilepsy Patients In Study

A Medtronic Inc. (MDT) device that delivers electrical pulses to the brain helped some patients in a study who were stricken with hard-to-treat cases of epilepsy, paving the way for a U.S. regulatory filing, the company said Monday.

The deep brain-stimulation technology could make Medtronic a competitor to Cyberonics Inc. (CYBX), which thus far has a monopoly in the market for treating severe epilepsy cases with stimulation devices. Shares of Cyberonics moved up Monday, however, and were recently up 4.9% to $17.61 after hitting $18.27 earlier.

Having the marketing muscle from much-larger Medtronic behind device-based epilepsy treatment may help more than it hurts. Also, Medtronic's entry into this market could put Cyberonics in the medical device giant's crosshairs, Lazard Capital Markets analyst Sean Lavin suggested in a note to investors Monday.

"We believe that Cyberonics likely becomes a potential Medtronic acquisition target as Medtronic could sell both products with one sales force," he said. He called Cyberonics "the real beneficiary" of Medtronic's data release.


Competition is good if it benefits us all.
 

Endless

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A date has been set for pre-market approval of the deep brain stimulation device.

http://www.massdevice.com/news/fda-sets-panel-date-medtronics-dbs-epilepsy-device

The Food & Drug Administration's Neurological Devices Panel will meet March 12 to discuss pre-market approval of Medtronic's deep-brain stimulation system for epilepsy.

Medical devices giant Medtronic Inc. (NYSE: MDT) will go before a Food & Drug Administration panel in early March to seek pre-market approval for its deep-brain stimulator for epilepsy.

The Center for Devices and Radiological Health set a March 12 date for its panel to discuss the company's implantable device, which stimulates the left and right anterior nucleus of the thalamus to reduce seizures.

In December, Medtronic released the results of a pivotal study of 110 patients with an average age of 22 years old that showed a 41 percent reduction in seizures one year after implantation, a 56 percent reduction at two years and a 68 percent reduction at three years, in conjunction with anti-seizure medication.

The agency is seeking public comment on the issue until March 5.
 
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