February 27, 2009: Implantable Device Replaces CPAP

[mdpooch]

Ok folks here is a bit more information on the stimulators, what I have learned so far..... three and a half years ago my mother got sick had to have surgery-several times. She is a diabetic and it was controlled by diet at that time. THEN.....she started having pain in her chest-abdomen area. Took her to several doctors-some thought it was because my dad just passed away-(buttheads) and some really did see a physical problem, they took care of the obvious. she was finally diagnosed as having Chronic Gastroparesis-and for those out there that dent know what that is...It is when your stomach don't digest food as it is supposed to-for instance she would eat a egg and it would take 900 hours to digest it, basically not doing its job. We seen several doctors on the way, including Mayo Clinic which in my opinion they told the same as others BUT they new about these stimulators and didn't say a dang thing. During the trials and tribulations of this journey my mother become deeply depressed. My mother attempted suicide at thanksgiving and Xmas day this past year just because she no longer could deal with the pain. I immediately got on the internet to see if anything out there new was available-(she is 69) I have searched the net several times to find anything that might be possible. I come across the Gastric Stimulator on the internat called medtronics and dealt with some very awesome people at that company, they had me the information on this the next day thru fedex-then they follwed up with me and the doctors currently doing this. I took a trip to Montana and took the information to her primary and he got the info to her gastroentologist-they had never heard of the devices. Any how Dr Jim got on the phone and made the necessary phone calls. This is what I know-we will fly to mississippi the first day we meet the doctor(he invented this product) the next day she will be in testing the third day they will laproscopically insert the two devices-one for the stomach and one for the lower bowel. then we wait five days to see if the devices will work for her. If they work they will then surgically implant them. The devices are FDA approved, Medicare is paying for them as they have already approved the surgery, they do have batteries in the devices and depending how strong the stimulation is needed is as how long they last then if all goes well we will fly to mississippi every three months to have them checked and yes eventually they will need relaced again. I will be taking my laptop with me as I will keep everyone informed -I believe people need to be aware of these as there are many people out there suffering and especially if they can be used to improve quality of life

[Ms Piggy]

Sorry to hear of your mother's problems. thank goodness she as you looking out for her.
Hope it's all successful, best wishes. let us know how it works out.

[OCNorsk]

If it works for people, great, but it won't be me.

[roster]

Ok folks here is a bit more information on the stimulators, what I have learned so far..... three and a half years ago my mother got sick had to have surgery-several times. She is a diabetic and it was controlled by diet at that time. THEN.....she started having pain in her chest-abdomen area. Took her to several doctors-some thought it was because my dad just passed away-(buttheads) and some really did see a physical problem, they took care of the obvious. she was finally diagnosed as having Chronic Gastroparesis-and for those out there that dent know what that is...It is when your stomach don't digest food as it is supposed to-for instance she would eat a egg and it would take 900 hours to digest it, basically not doing its job. We seen several doctors on the way, including Mayo Clinic which in my opinion they told the same as others BUT they new about these stimulators and didn't say a dang thing. During the trials and tribulations of this journey my mother become deeply depressed. My mother attempted suicide at thanksgiving and Xmas day this past year just because she no longer could deal with the pain. I immediately got on the internet to see if anything out there new was available-(she is 69) I have searched the net several times to find anything that might be possible. I come across the Gastric Stimulator on the internat called medtronics and dealt with some very awesome people at that company, they had me the information on this the next day thru fedex-then they follwed up with me and the doctors currently doing this. I took a trip to Montana and took the information to her primary and he got the info to her gastroentologist-they had never heard of the devices. Any how Dr Jim got on the phone and made the necessary phone calls. This is what I know-we will fly to mississippi the first day we meet the doctor(he invented this product) the next day she will be in testing the third day they will laproscopically insert the two devices-one for the stomach and one for the lower bowel. then we wait five days to see if the devices will work for her. If they work they will then surgically implant them. The devices are FDA approved, Medicare is paying for them as they have already approved the surgery, they do have batteries in the devices and depending how strong the stimulation is needed is as how long they last then if all goes well we will fly to mississippi every three months to have them checked and yes eventually they will need relaced again. I will be taking my laptop with me as I will keep everyone informed -I believe people need to be aware of these as there are many people out there suffering and especially if they can be used to improve quality of life

Your mother raised a great child. Best of luck to both of you.

[mdpooch]

Thank You rooster!! I see your location is the sofa, is that really where you are? LOL you have brightened my day!

[split_city]

Just an bit of extra info. I have been informed that Inspire is a spin out of Medtronic who did an original human study about 15 years ago using a similar device, but appeared to put the idea on the backburner. It now seems that they've dusted it all off to see if they can make a go of it. We are actually in the process of running trials with a similar device (http://www.onemedplace.com/database/list/cid/10499/). Looks like the Apnex we will be competing with Inspire.

[kebsa]

mdpooch
i will keep my fingers crossed for your mum, my experience with a medtronic implanted device was life changing and after 8 years of good pain control i miss my device now- hopefully i will be able to get it replaced soon but they will trial a spinal cord stimulator (also by medtronic) in a similar way that they are trying with you mum- if that works it will be made permanent and will be a drug free option after over 15 years of heavy pain medication use (and that actually might help my sleep apnea some) if not they will place another pump like i had before- either way i know that it is only a matter of time before i am back to decent pain relief- based on my experience with an implanted device, if they come up with one for sleep apnea, once it has been thoroughly trialed, i would be quite happy to give it try! i have become quite attached to my bedside buddy but i must admit that my home is looking more and more like a medical supply wharehouse- these devices allow life to continue like normal based on my experience with pain pump- i could actually forget that i had complex regional pain syndrome at times, now, how insurance would deal with them i don't know! my pain pump was around the $15,000 mark just for the hardware so they are not cheap options but with the pain pump i went from not being able to work and needing home carers so the $15000 saved a lot of money but you can buy a lot of cpap gear for that!

[roster]

Just an bit of extra info. I have been informed that Inspire is a spin out of Medtronic who did an original human study about 15 years ago using a similar device, but appeared to put the idea on the backburner. It now seems that they've dusted it all off to see if they can make a go of it. We are actually in the process of running trials with a similar device (http://www.onemedplace.com/database/list/cid/10499/). Looks like the Apnex we will be competing with Inspire.

SC,

Good luck to you and Apnex. May the better mousetrap win big in a free market. Thanks for keeping us informed.

BTW, I would have named the company Apnix.

Description
Apnex Medical is a medical device company developing therapies for obstructive sleep apnea, a disorder that interrupts breathing during sleep. The company's technology is an implantable neurostimulator designed to open the airway muscles that can close during an apnea episode.

Products / Services
The Apnex device is similar in design to a cardiac pacemaker, but rather than connecting to the heart, the device attaches to a nerve in a patient's airway.


Technology / Differentiation
Apnex's sleep apnea device stimulates nerves controlling a patient's airway, keeping it open during sleep and preventing nighttime breathing interruptions responsible for a number of medical ailments.

Market / Customers
The market for sleep apnea equipment in the U.S. is currently estimated at $1.3 billion a year. The incidence of sleep apnea continues to rise.


Funding
May 15, 2007. Apnex-Medical raised $16.1 million in a first round of funding. Participants included Domain Associates, New Enterprise Associates, Polaris Ventures Partners and Apnex Chairman Michael Berman.

Status
Apnex is a development/pre-clinical stage company with plans to begin clinical trials in 2009 and commercial to launch in the United States by 2012.

Does your device stimulate beer bellies?

Sorry, I still occasionally commune with Snoredog.

[mdpooch]

thank you kebsa...I appreciate the thoughts and could use them

[rested gal]

We are actually in the process of running trials with a similar device (http://www.onemedplace.com/database/list/cid/10499/). Looks like the Apnex we will be competing with Inspire.

Hiya split_city!

Perhaps you could answer a couple of questions I've thought of.

At this link from 2003 , I read this:

Such stimulation, delivered below the arousal threshold

I wondered exactly what definition they were using for "arousal threshold." An arousal by PSG standards, I would hope. Not just "patient woke up and was aware of being awakened."

I'd think arousal thresholds (even by PSG standards) could be quite different from patient to patient.

In regard to the hypoglossal nerve stimulators being trialed, how would the initial programming (titrating) of the device for each patient done? If/when these devices come to market, how would that be done in a way to know for sure what the threshold of arousal caused by the device was, for each patient?

A PSG titration with the device in use jumps to my mind as being the best way to program the device for each individual. But that would be expensive and likely to meet with resistance by patients who just will NOT go to a sleep lab for overnight PSG.

Perhaps Level II portable home monitoring equipment might have a place in the initial "titration" of the stimulator device, as well as for any later programming adjustment that the physician thinks might be needed?

Looking farther down the path...

This, on the Apnex site:
The programmer system is used by the physician to control and program the Neurostimulator during surgery and therapy titration.

And this, on the Inspire site:
"A physician controller unit, used during visits to the patient's treating physician, is used to monitor the therapy and make adjustments to the device as needed for the patient's unique physiology"

On later doctor visit checkups, with the patient sitting there wide awake, how will the physician programming the device know that any adjustments he chooses to make might not cause arousals that the patient would not be aware of when sleeping? Arousals that could fragment sleep architecture?

What would be some reasons, presented by a wide awake patient at a follow up doctor visit, that would warrant having the physician adjust the programming right there in the office?

Perhaps there has already been research into what level of neurostimulation of the hypoglossal nerve does, indeed, cause "arousals" in most people. Kind'a like the "pressure of 10 prevents apneas in most people" studies that lead to development of the A10 algorithm by ResMed.

Just wondering.

This really is fascinating stuff.

[Babette]

I'm guessing the next things after this will be a black market in "physician's" controllers, and a bunch of rebel former CPAPtalkers exchanging programming ideas on-line....

Gee, are we that obvious?

Yup, I want my own Physician's Controller. You guessed it.

It's not that I want to HURT my Physician, I just want to jolt her a little now and again....

LOL,
Babs

[Babette]

Does your device stimulate beer bellies?

Sorry, I still occasionally commune with Snoredog.

Can't think of a better drinking buddy. Unless it's my Dad. Looking forward to the day I can have a beer with both of them again.

Cheers,
B.

[split_city]

Does your device stimulate beer bellies?
Sorry, I still occasionally commune with Snoredog.

. No my device for the beer belly would be to get an oversized plunger, suction it to the belly and then pull the plunger up and attach it to the roof to relieve pressure in the abdomen. What do you think??

Perhaps you could answer a couple of questions I've thought of.

At this link from 2003 , I read this:

Such stimulation, delivered below the arousal threshold

I wondered exactly what definition they were using for "arousal threshold." An arousal by PSG standards, I would hope. Not just "patient woke up and was aware of being awakened."

Bummer, I can't get access to the full article. My initial impression would be that arousal threshold would be based on "patient woke up and was aware of being awakened" during the earlier pilot studies. We implanted the first Apnex device the other night and will be performing a titration night in about a month's time. I would anticipate that the titration would be peroformed like any CPAP titration i.e. maintain airway patency, stabilise O2 sats and abolish sleep-disordered breathing related arousals. I would be very keen to watch the titration if it's being run in our lab.

I'd think arousal thresholds (even by PSG standards) could be quite different from patient to patient.

That is correct be it by using this device or as a consequence of sleep-disordered breathing. A low arousal threshold i.e. arouse easily following a stimulus, may actually perpetuate OSA. You have a period of hyperventilation following an arousal and this period leads to a reduction in CO2 in the blood. Thus, this turns off breathing and stimulation of the airway muscles, leaving the airway more vulnerable to collapse. There is potential for drug companies to design drugs to increase the threshold in patients with a low threshold.

In regard to the hypoglossal nerve stimulators being trialed, how would the initial programming (titrating) of the device for each patient done? If/when these devices come to market, how would that be done in a way to know for sure what the threshold of arousal caused by the device was, for each patient?

You pretty much answered that below i.e. PSG

A PSG titration with the device in use jumps to my mind as being the best way to program the device for each individual. But that would be expensive and likely to meet with resistance by patients who just will NOT go to a sleep lab for overnight PSG.

Perhaps Level II portable home monitoring equipment might have a place in the initial "titration" of the stimulator device, as well as for any later programming adjustment that the physician thinks might be needed?

I think the current devices would require an in lab PSG for intitial titration purposes. But who knows, just like APAP, an auto-stimulating device down the track could be used in patients who don't want to come into the sleep lab.

Looking farther down the path...

This, on the Apnex site:
The programmer system is used by the physician to control and program the Neurostimulator during surgery and therapy titration.

And this, on the Inspire site:
"A physician controller unit, used during visits to the patient's treating physician, is used to monitor the therapy and make adjustments to the device as needed for the patient's unique physiology"

On later doctor visit checkups, with the patient sitting there wide awake, how will the physician programming the device know that any adjustments he chooses to make might not cause arousals that the patient would not be aware of when sleeping? Arousals that could fragment sleep architecture?

What would be some reasons, presented by a wide awake patient at a follow up doctor visit, that would warrant having the physician adjust the programming right there in the office?

Those are all really good questions and I don't know the answers. It's all in the early stages and these issues are currently being discussed between the research group and the clinicians. I'm not actually involved with this trial but I certainly will keep you up-to-date

[rested gal]

I think the current devices would require an in lab PSG for intitial titration purposes. But who knows, just like APAP, an auto-stimulating device down the track could be used in patients who don't want to come into the sleep lab.

LOL! Now why am I suddently thinking of "Terminal Man" ?

Thanks for your entire post, split_city. Will be very interested in hearing anything you feel comfortable sharing as the trials progress.

[roster]

Here is a video about an implanted device for treatment of epilepsy:

https://www.youtube.com/watch?v=kjB2TaeL9d4

jda100,

I note in the video they allow the patient to upload the data via the internet to the doctor but there is no mention of allowing the patient to have software to look at the data.

But your are correct, with the apnea device, we are going to demand our own software. And why not?