Incredible news for 'Central' S A folks!

[bdonahueweedman]

[/b]Hi everyone;
About a year ago I came to this forum, uninsured and panicky, looking for help and got a LOT of help from a lot of very nice, patient people, especially one person, and I know she knows who she is but would probably not want to be singled out. I was uninsured, and like many, had a tremendous amount of difficulty getting the hang of my machine, in spite of a LOT of My Brilliant Buddy's time, patience and knowledge. She was able to get me waaaayy more comfortable than the breathing tech I had. My Mother was very sick and I was (still am) her full time caregiver and there were 2 moves involved and just a lot of emotional family stuff I just couldn't devote the time that I needed to my treatment at that time, so I shamefully put it on the back burner.

About 6 months ago on a routine visit to the Sleep Doc with my Mother (it was HER appointment) and he said to me "Would you be interested in participating in a study for a device that is kind of like a pacemaker, but instead of starting your heart it pushes a breath into your diaphragm and gives you a breath when you are having an apnea. Its for CENTRAL sleep apnea folks only, and right now they are recruiting heart failure patients with central sleep apnea and they need 20 people with severe CSA from the US for the study. There are already folks in Japan and other countries where their "FDA" isn't as strict. This study is the last hurdle before the device is given to the FDA for approval. (I *think* they are primarily looking for folks in the Ohio, PA area, but I know of one woman who I * believe* wanted in so bad she just flew to one of the cities for the treatment). Hopefully it will get the thumbs up by the FDA and it will help many CSA patients.

Well I wasn't exactly sure what he was talking about but long story short I DID qualify because of the medicine I take called Suboxone, which was making it hard for me to breathe. Normally this device is used for heart failure patients with CSA, but my sleep Doc really pushed for me to get in and the folks at Respicardia said Yes. They are finding people have many other needs for this other than just heart failure patients. I can tell you that the things that this device does are incredible and I am FINALLY getting good sleep! So we pray that the FDA approves it, but until then I know they are still looking for folks who want to do the research study; apparently it's not as easy to qualify as I thought. I asked the Respicardia folks if I could talk about the study here and they said I could, and just direct folks to the website if they'd be interested in qualifying for the study.

I want to stress that I do not work for this company, I am not getting paid to say any of this. Anybody who knows me knows that once I find something I like I cant shut up about it, whether it be Lady GaGa, a Movie, the INCREDIBLE U2 concert that is on tour right now, and now this! The great thing about this particular forum was that people were helping each OTHER find solutions, and there is so much good info on here! I don't get paid anything except like any research study, all of the equipment, appointments etc are paid for. All I get out of it is the device and all follow up work etc. I simply wanted to try and contribute something to this board as so many people helped me at the beginning. I'm not sure if I'm breaking the CPAPTALK law talking about this, I certainly hope not because I want my CSA friends to know that hopefully a really cool alternative could be in the not-too-distant future! Its an incredibly brilliant little thing; when I have an apnea it pushes a breath into my diaphragm to get me breathing again. Of course those are MY words, and you would be best served to check out the website if you're interested. I'm not sure if we are allowed to leave links here or not, but basically it's the name of the company I spoke of earlier plus dot com, and you would click on "patients" to the right at the top, then choose The remedēTM System. Though this device is geared towards heart patients with CSA, but it turns out that they are finding people (like me) with the Suboxone and other reasons why this device could help them.

I'd be happy to tell anybody with questions what MY experience has been if you want to private message me, again NOBODY is soliciting anything here; I'm just trying to share some really (*I* think anyway!) exciting news that hopefully will help some CSA folks, and let you know about this clinical trial still going on, in case anyone is interested.

Stay Well,
Beth

[NightMonkey]

Thanks for the info.

Link http://www.cardiacconcepts.com/respiacardia

The remedē System is an implantable medical device that is being investigated in a clinical research study for the treatment of Central Sleep Apnea in patients with Heart Failure.

It consists of three implantable components:

◦remedē Pulse Generator comprised of electronic circuitry components and a battery, which are hermetically sealed in a titanium case
◦remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves
◦And a sensing lead to detect respiration

The remedē System also includes an external programmer used to change the pulse generator settings or to review diagnostic data via telemetry.


The remedē pulse generator delivers electrical pulses via a transvenous stimulation lead positioned within a vein close to one of the phrenic nerves. The phrenic nerve stimulation results in restoration of breathing to a more natural pattern. A more natural pattern of breathing may allow for better oxygenation, less activation of the sympathetic nervous system, and improved sleep.

The remedē System is designed to deliver electrical pulses at night during sleep to restore natural breathing.

Brought to you by another bunch of obscene-profit-seeking (sarcasm) capitalists.

So happy for you Beth!

[NightMonkey]

Here was Beth's intro to the forum viewtopic/t65725/viewtopic.php?f=1&t=53 ... 71#p494271

[avi123]

Sounds to me like an invasive approach like in a pacemaker: remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves, and a sensing lead to detect respiration.

As such, its cost, plus the implantation, could be between $25,000 and $35,000.

Beth, you posted: I'd be happy to tell anybody with questions what MY experience has been if you want to private message me, again NOBODY is soliciting anything here; But, actually you were (are) a plain drug abuser. So how can I trust you about solicitation?

[NightMonkey]

Sounds to me like an invasive approach: remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves, and a sensing lead to detect respiration.

... and your point is?

[bdonahueweedman]

<<As such, its cost, plus the implantation, could be between $25,000 and $35,000>>

Actually the device alone is closer to 60. That's why it might behoove someone without insurance who is desperate to try and qualify in the study. Then its FREE, and FREE happens to be my favorite. I would imagine it only "seems invasive" if you are happy with your treatment. I would think if you are a heart failure patient struggling with a remedy that works, a small incision with twilight sleep anesthesia and basically an outpatient procedure,( except they want to keep you overnight for observation) doesn't seem like that big of an intrusion. But hey, all I did was supply information. If you find it interesting great, if you don't that's cool too. I just thought that this was a place for the exchanging of information. And PS Thanks Monkey

[BleepingBeauty]

Hey, stranger. Nice to see you here again.

Thanks for posting that interesting info about the clinical trial on this device. I'll stick with my trusty machine because it works so well for me, but for anyone who just can't make this therapy work and suffers with centrals, this could be a great option for them. And as you say, if someone in that position can take advantage of this for free, with follow-ups included, all the better.

I'm glad it's working for you and you're finally getting some good sleep.

*And don't pay avi any mind. He's foe'd plenty of us around here because we so often disagree with the inane comments and erroneous assumptions he makes. I'm sure that, unless someone comes along and quotes my post, he'll never see this comment from me.

[bdonahueweedman]

Hey, stranger. Nice to see you here again.

Thanks for posting that interesting info about the clinical trial on this device. I'll stick with my trusty machine because it works so well for me, but for anyone who just can't make this therapy work and suffers with centrals, this could be a great option for them. And as you say, if someone in that position can take advantage of this for free, with follow-ups included, all the better.

I'm glad it's working for you and you're finally getting some good sleep.

*And don't pay avi any mind. He's foe'd plenty of us around here because we so often disagree with the inane comments and erroneous assumptions he makes. I'm sure that, unless someone comes along and quotes my post, he'll never see this comment from me.

I thought of you right away, but I knew you had this thing DOWN. Its been a miracle for me and I will always remember your kindness. Hope you are well, LV

[ozij]

Thank you for posting that info, Beth. I am sure the information will be a help to many.
I'm very glad you are sleeping better.

[JohnBFisher]

... Brought to you by another bunch of obscene-profit-seeking (sarcasm) capitalists. ...

... As NightMonkey types on a computer using a system that at one time would have literally cost hundreds of thousands of dollars using a forum that once would have cost hundreds per year. ...

The situation just drips with irony. And a certain amount of comedy at the same time.

Thank God for those capitalists and researchers, who hunt for new ways to address old problems. Yes, they recover their costs and try to make some money in the process. But competition will drive down the costs and bring the product within reach for the rest of us. Even in a "broken system" such as the medical industry that will eventually happen.

Beth, thank you for posting this. It will be interesting to see how this progresses. The costs are definitely out of my range. But it will be interesting to see if this leads to further developments.

[NightMonkey]

Well at least you get it John.

But my sarcasm was not addressed to you. It was addressed at those who whine here regularly about "those who are in medicine for the profits".

I may be a youngster on the forum but I learned quickly in life that the best goods and services at the lowest prices come from people seeking profits. That is true in electronics, automobiles, groceries, and medicine. Why do so many not understand that? (Probably because they were educated in government monopoly schools?)

Since my sarcasm was a little too veiled, let me say Beth's testimony ("I can tell you that the things that this device does are incredible and I am FINALLY getting good sleep!") is a hearty endorsement of capitalism and free markets whether she realizes it or not.

Yes, you are correct John, if the product proves to be very beneficial for others, competition will arise and the price will fall and the product will get even better. That is as long as government regulators don't screw up the market.

[no_more_headaches]

I don't think there is a problem with people making profit. It's about the middle man (Insurance people) that don't want any of us that need insurance to have insurance.
Insurance is about balancing out life's inequities and the insurance people through the profit motive would just prefer you pay and never use it.

[NightMonkey]

If you broaden your view of the insurance industry and look at how the insurance industry is regulated and who traditionally pays the premiums your opinion might change.

As for government regulation, all fifty states have an insurance department that tightly regulates health insurance and health insurance companies. They even tell them what they can cover and what they must cover. The government also tells me I cannot buy health insurance from a company in another state. The government insurance bureaucrats in the state capitals are in bed with a few established companies and the parties together make it difficult for new companies to survive and otherwise kill competition. The result is you do not have a free market and the insurance companies operate not for the customer but for the government bureaucrats and their own jobs and profits. Get government out and competition will spring up, prices will go down, the consumer will have more types of policies to choose from, and prices will fall.

Now about who pays the premiums, this has traditionally been the employer. So the ones who seek the services have always thought the services were at no cost to them personally - the employer pays the premium and the insurance company pays the medical costs. When a consumer thinks medical services are free he spends like a sober politician - very freely that is. Most employers have finally awakened to this problem and are dropping policies or changing them so the employee will bear significant out-of-pocket expenses each year. So this problem will gradually go away.

But the government bureaucracies seem to last forever and I am less hopeful about having a free market in health services and health insurance in the next few years.

In summary, the major problem is government regulating away the free market and what always comes from this in any field is less consumer choice, higher prices, and lower quality.

[bdonahueweedman]

Sounds to me like an invasive approach like in a pacemaker: remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves, and a sensing lead to detect respiration.

As such, its cost, plus the implantation, could be between $25,000 and $35,000.

Beth, you posted: I'd be happy to tell anybody with questions what MY experience has been if you want to private message me, again NOBODY is soliciting anything here; But, actually you were (are) a plain drug abuser. So how can I trust you about solicitation?

<<Beth, you posted: I'd be happy to tell anybody with questions what MY experience has been if you want to private message me, again NOBODY is soliciting anything here; But, actually you were (are) a plain drug abuser. So how can I trust you about solicitation?>>

Ahhhh NOW I see what all the fuss was about. Keep walkin folks, nothin to see here. Been dealing with attention-starved A-Holes like this one for 25 years. Nobody pays any attention to them so they leap on anything they can to get tongues-a-waggin. Case in pont: Avi

But Goodness me Avi makes a BRILLIANT argument: Who is going to trust a drug user about SOLICITATION?! Huh? Acutally Avi? You got me, buddy! The mask is off. This is what I do; I got hooked on drugs, then I go look for studies I can get into for SLEEP APNEA, so I can sucker a bunch of un-insured people into trying to get a free device that could change their quality of life for the better. I've been waiting for someone to bust me, and dang it if it isn't a Lil feller with 2 fancy lookin cowboy's drinkin wine as an avitar.

Too bad YOU weren't prosecuting Casey Anthony, buddy; you are ONE----- SHARP---- Muddy Hucky! Man NUTHIN gets by Avi!

Poor feller prolly thought I forgot all about him...sorry to keep you waiting buddy. Today I took my Mother to a Doctor to find out she has a positive Biopsy. Why not rough her up a bit? She takes pain medicine because she DOESN'T HAVE ANY MUSCLES IN HER NECK. Go on Hot Shot. I'll print them out and read them to her tomorrow when I'm changing her diaper. That sound about right for ya?
Did you get what you needed tonight?

Sleep well Avi

[BleepingBeauty]

Hey, stranger. Nice to see you here again.

Thanks for posting that interesting info about the clinical trial on this device. I'll stick with my trusty machine because it works so well for me, but for anyone who just can't make this therapy work and suffers with centrals, this could be a great option for them. And as you say, if someone in that position can take advantage of this for free, with follow-ups included, all the better.

I'm glad it's working for you and you're finally getting some good sleep.

*And don't pay avi any mind. He's foe'd plenty of us around here because we so often disagree with the inane comments and erroneous assumptions he makes. I'm sure that, unless someone comes along and quotes my post, he'll never see this comment from me.

I thought of you right away, but I knew you had this thing DOWN. Its been a miracle for me and I will always remember your kindness. Hope you are well, LV

Thanks, I'm doin' fine.

As to the clinical trial for this device, I don't think I'd be eligible for it (even if I wanted to get in on it) because I don't just have centrals; my unreated OSA is pretty severe. But I'm really glad it's proving to be a great solution for you (and hopefully anyone else who can take advantage of it).

Tell Robert I said hello, and be sure to give Martha my best.