February 27, 2009: Implantable Device Replaces CPAP

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

split_city wrote:

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

hhmm do you wish to plan to change the stimulating settings based on the software output?

IMO, I think we need to be careful at this stage about what we expect patients to do once on treatment. While I agree that changing CPAP settings can easily be done at home by the patient (whether it's right or not is up for debate ) and cuts out a lot of vists to doctors and DMEs, I think we should be cautious with these stimulating devices. You must remember, they aren't out on the market yet and trials have only started. We don't know what effect over stimulating the hypoglossal nerves may have. We just need to sit back, relax and see what the results bring to the table

rooster wrote:

split_city wrote:

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

hhmm do you wish to plan to change the stimulating settings based on the software output?

IMO, I think we need to be careful at this stage about what we expect patients to do once on treatment. While I agree that changing CPAP settings can easily be done at home by the patient (whether it's right or not is up for debate ) and cuts out a lot of vists to doctors and DMEs, I think we should be cautious with these stimulating devices. You must remember, they aren't out on the market yet and trials have only started. We don't know what effect over stimulating the hypoglossal nerves may have. We just need to sit back, relax and see what the results bring to the table

I will not try the device unless I can see every morning how many apneas, their length, and how many hypopneas the device recorded. If it shows a bad night, I would add my CPAP to the treatment until I could get back into the doctor's office.

As far as the patient changing the stimulating settings, take an intelligent patient who is fully involved in his therapy; who is well-studied in sleep apnea and the device; who knows how he feels in the morning; who has some recollection of how the night went; who is able to read the reports immediately upon arising and spend significant time in analysis; who can spend hours each month checking on his therapy; who can call the doctor if he thinks it is necessary; and who may be unable to go to work if the settings are wrong.

Now take a doctor, who has to be told how the patient felt in the morning and what the patient's recollections of the night were; who has to be a good listener and interperter; who has ten minutes a couple of times per month to spend on this patient; who will still feel good the next day if the settings are wrong; and who will still get paid if the settings are wrong.

Which one will do the best job of managing the therapy?

Now I know this is about an exceptional patient and the country is loaded with patients who can't even figure out which pill to take at which time of day. But health is a personal responsibility. Bad patients are probably destroying themselves in other ways also, such as bad diet, inactivity, smoking, heavy drinking, or illegal drug use. I hate to keep bringing up diabetes, but we do insist patients read their own BG levels and adjust their diet and insulin injections accordingly.

It will be interesting to see how sleep apnea treatment continues to develop.

SC, It is great to have you as a member here.

Regards,

split_city wrote: ..........
In saying that, Im sure that software designed to evaluate OSA symptoms will be made available when using these stimulation devices. ........

split_city wrote:We implanted the first Apnex device the other night and will be performing a titration night in about a month's time.

rested gal wrote:

split_city wrote:We implanted the first Apnex device the other night and will be performing a titration night in about a month's time.

I'm curious. Why will there be a delay of a month from the time the device was implanted before a PSG titration will be done?

Two local med-techs vie in sleep-apnea market
Inspire Medical, Apnex preparing to test implants
By Christopher Snowbeck
csnowbeck@pioneerpress.com
Updated: 03/09/2009 09:59:52 PM CDT


Suddenly, the Twin Cities seems like a hotbed for research into implantable devices that might tame sleep apnea.

Inspire Medical Systems of Brooklyn Park says it expects to begin implants in the United States this month of an investigational medical device designed to use electrical stimulation to prevent the closure of the upper airway while people sleep.

Such a treatment, the company hopes, could help people with obstructive sleep apnea — a common condition in which recurrent blockages of the upper airway can disrupt a patient's sleep, reduce oxygen levels in the blood and contribute to other health problems.

Hennepin County Medical Center is one of a handful of U.S. hospitals that will be part of a government-approved study to test the company's device in a small group of patients, Timothy Herbert, the president of Inspire Medical Systems, said Monday.

Last month, officials with Roseville-based Apnex Medical — a startup that's also developing a "neuromodulation" device for sleep-apnea patients — said they expected doctors outside the United States would perform the first implant with their investigational system this quarter.

The technology behind Inspire Medical's device was first developed at Medtronic, where Herbert worked on the project. The startup was formed in 2007 when the intellectual property and technology behind Medtronic's device was licensed and spun out to Inspire Medical.

"At the time, this is something (Medtronic

wasn't) focused on," Herbert said.
Medtronic maintains a minority ownership position, he said, and provides contract manufacturing to Inspire Medical Systems.

The sleep-apnea devices of both companies consist of a pulse generator that is surgically implanted in the chest and a wire that delivers electrical stimulation to the hypoglossal nerve in the neck. That nerve leads to the tongue.

Inspire Medical's device uses a pressure sensor to monitor a patient's respiratory effort during sleep so that nerve stimulation can be timed to match respiration. Patients are given a programming device to turn the system on at bedtime and off during nonsleep hours.

The stimulation is sufficient to trigger a nerve response but not so great that it disturbs a patient's sleep.

Beyond Inspire Medical and Apnex Medical, a Canadian company called Victhom Human Bionics Inc. also is developing technology for a neuromodulation device to help sleep apnea patients.

Apnex Medical says it has been backed so far by $16 million in private-equity financing; Inspire Medical did not say how much money it has raised.

Christopher Snowbeck can be reached at 651-228-5479.

ozij wrote:

Patients have a programming device that is used to turn the device on at bedtime and to turn the unit off during non-sleep periods. The stimulation delivered is sufficient enough to evoke a response from the nerve but at a low enough level to not disturb the patient's sleep. 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

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First time I've heard the on off button called a programming device!

O.