Diaphragm Pacing System Awaiting FDA Approval for ALS

Sequoia just informed me of this article. Many of us are well aware of this procedure and some have even received it. But here is a recent update.

Diaphragm Pacing System Awaiting FDA Approval for ALS | MDA/ALS Newsmagazine

Only about 4000 of the 30,000 PALS in the US will be able to benefit from this. It will only work on PALS with very little diaphragm muscle loss. The best candidates are the newly DX PALS. This is according to the research manager at our ALS clinic.

Just saw this article thought it was relevant and interesting

Breakthrough For Lou Gehrig's Disease: Healthy For Life from the Eyewitness News Newsroom

that was a pretty good article Ted. Thanks for posting it.

Ted, I wonder when that article was written. My guess is it was a few years ago. It quotes Dr. Onders as saying only three ALS patients have been treated. In fact I think several dozen have now been implanted.

The trial did 100 PALS. The unfortunate thing about the Pacer is that it will only work for a small # of PALS, about 10%, and works only if your diaphragm muscles are not affected. It works best in the VERY newly DX. Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS) - Full Text View - ClinicalTrials.gov This is the link to the trial.

sadiemae said:

The trial did 100 PALS. The unfortunate thing about the Pacer is that it will only work for a small # of PALS, about 10%, and works only if your diaphragm muscles are not affected. It works best in the VERY newly DX. Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS) - Full Text View - ClinicalTrials.gov This is the link to the trial.

Click to expand...

You stated "only if the diaphragm muscles are not affected". My question for that is why would you need to do this if your diaphragm is not affected?

Exactly my question. I should have said that "it doesn't work well with PALS who have already lost a lot of diaphragm function." I am quoting what the research manager Emailed me. She said it wouldn't work for my PALS, and his FVC is almost 70. Very disappointing.

Yes, it is disappointing. I inquired about it but my FVC was already too low. I was told it had to be over 60% for anyone to be considered. So, a short time later I got a trache.

The 21st Annual Symposium on ALS/MND has taken place and there were a number of presentations related to the use of the Pulmonary Pacer in ALS.

Session 11B(C96) and Theme 8 (Posters P149, P150, P151) in the handbook:

MND Association - Abstract Book 2010

My understanding is enough neuromuscular junctions (the contact between the neurons and the muscle fibers) must be healthy in order for the pulmonary pacer to be effective. I would have thought an FVC of 70 implied the sustainment of a large number of neuromuscular junctions. The research reports suggested the health of these junctions is sustained longer due to pacing.

Somewhere there were some comments that the fda might have 'pigeon holed' the consideration of the technique because more than seventy five days have passed since the pacer's application was approved. I am not sure, but I think the seventy-five days relates to the consideration given by medical experts . . . after that I would expect their report to be advanced to legal. The seventy-five days probably completely by early January. The approval of the application itself was not reported until a month or two after some news was expects.

I have no news on the matter at this time, but remain confident the fda will form a formal opinion, whether favorable or unfavorable - or even report a return of the matter for further case studies (if they are unable to draw a conclusion based only on the submitted results).

Thanks so much for the link, MuonOne. The handbook was extremely informative in many aspects.

We are hopeful that the device will receive approval while my husband can still be considered as a candidate for implantation.

I note that you are a researcher. Just in case no one has told you lately, we are all desperately thankful for your help and that of others in your field. Please don't give up.