These DPS notices say news is good for over 50% of the newly diagnosed ALS patients

Status
Not open for further replies.

MuonOne

Active member
Joined
Mar 8, 2010
Messages
79
Country
US
State
New York
City
New York
The language of this new and latest notice, you may need to 'login' to their web site to read it, suggests that more than fifty percent of newly diagnosed ALS patients are likely eligible for DPS, whereas other notices have either not articulated an estimate or offered an estimate that implied only about ten percent of new cases are probably eligible.

Medscape: Medscape Access

"Of 5600 new cases diagnosed each year, an estimated subset of 3300 patients with both respiratory failure and an intact phrenic nerve could benefit from this therapy, the company statement notes."

Ah, Ha! The company has a lengthy (PDF) news release related to the FDA approval here:

Synapse :: News :: Media Center

There is even an brief explanatory video on their web site:

Synapse :: Media Center :: How the NeuRx DPS™ Works
 

MuonOne

Active member
Joined
Mar 8, 2010
Messages
79
Country
US
State
New York
City
New York
I had not realized what Duff Wilson points out in this Opinion piece on the NeuRx DPS for ALS:

F.D.A. Approves Breathing Device for A.L.S. Patients - NYTimes.com

The current approval by the FDA does _NOT_ mean the device is effective in ALS . . . rather, it means that the risks associated with its use in ALS patients is considered reasonably low by the FDA.

It does not mean the device is ineffective in ALS either, rather, its effectiveness remains to be proved. When there are very few patients, the time required to complete proper review can be very long, possibly more than one hundred years; can any patients wait that long?

I had thought the approval implied the FDA saw some effectiveness in the treatment, instead the FDA apparently remains in consideration of that issue.
 

Ladyinn

Distinguished member
Joined
Apr 7, 2010
Messages
398
Reason
PALS
Diagnosis
11/2009
Country
US
State
South Dakota
City
Custer
We spoke with the marketing person for this device yesterday. Notice I said the marketing person -- so consider his take on it is to sell. Currently the trial has shown that it does help ALS patients who received the device while they still have diaphragm muscles that are working. Those who wait to receive the implant after losing a significant amount of diaphragm muscles have less success.

Although the test has been conducted at nine different locations there is only one doctor who currently performs the procedure. He is located in Ohio. At the present time they are selling the device to other doctors who are being trained to perform the procedure. The cost for the device $21,000. This does not include a one night hospital stay, the surgeon when the anesthesiologist and all of their medications.

There are some insurances which are already approved and others are in the state of being approved. As we learn more or gather more information I will be glad to share it with you.
 

trfogey

Very helpful member
Joined
Jan 31, 2008
Messages
2,043
Reason
PALS
Diagnosis
07/2007
Country
US
State
NC
City
Raleigh

csgam

New member
Joined
Jun 3, 2010
Messages
5
Reason
PALS
Diagnosis
05/2010
Country
US
State
CA
City
Agoura Hills
Did some heavy research on this.

One Man's Opinion on the New FDA Approved Diaphragm Pacing System - Timing Challenges Abound

Many PALS were excited to hear about the NeuRx Diaphragm Pacing System by Synapse that was very recently FDA approved for ALS patients. The FDA granted a Humanitarian Device Exception (HDE). Will definitely help those with stimulatable diaphragms and experiencing chronic hyperventilation. Synapse estimates around 3,300 living PALS with both respiratory and intact phrenic nerves could benefit. Patient Q&A document can be seen here.

This typically outpatient procedure allows the patient to breathe using his or her own muscles for a longer period of time. Dr. Raymond Onders, co founder of Synapse Biomedical, started working with patients 15 years ago in Cleveland at University Hospitals Case Western. Early patients included Christopher Reeve. It has been used in partially and totally paralyzed non-ALS patients for quite some time with good success. A pair of clinical trials were conducted beginning in 2004 with ALS patients and produced the approval noted above. Link here.
Bottom line is I called Dr. Onders to learn more and inquire about my potential for qualification and the potential timeline to get an ALS Clinic affiliated hospital in Southern California to participate. He sent me a very nice note back and connected me with his staff. Wanted to share what I have learned from a practical, medical, and insurance standpoint at this time.

Practically, there is only one certified place to have this procedure done for ALS Patients today and that is with Dr. Onders' team at University Hospitals in Cleveland. See the current nationwide approved hospital and clinic map here. "The DPS is a Humanitarian Use Device approved by the FDA as an HDE the institution is required to obtain a local IRB review to treat patients with the NeuRx DPS(r) technology. This does not mean it is experimental or it will not be reimbursed by health insurance, it's just an FDA requirement as a HUD/HDE. "

Read the rest of this blog post at ALS Everyday Living: One Man's Opinion on the New FDA Approved Diaphragm Pacing System - Timing Challenges Abound.
 

sadiemae

Extremely helpful member
Joined
Sep 20, 2009
Messages
2,527
Reason
Lost a loved one
Diagnosis
09/2009
Country
US
State
NV
City
Reno
Good to know.
 

notgivnup

Senior member
Joined
Nov 8, 2010
Messages
833
Reason
PALS
Diagnosis
11/2010
Country
OS
State
Darkside of Moon
City
country
Does this mean medicare will cover 80% of the charge? Or is there a long way to go before it is approved by medicare?
 

MuonOne

Active member
Joined
Mar 8, 2010
Messages
79
Country
US
State
New York
City
New York
csgam, apparently I missed your post and should have responded earlier . . .

You used the term "hyperventilation," but I practically certain you mean "hypoventilation" because a hyperventilating person is a person who is breathing too much.

notgivnup,
With regards to Medicare, I have no idea but would suggest you contact your nearest ALSA organization or the national office of the ALSA - they should have some insight on this issue.
 

notgivnup

Senior member
Joined
Nov 8, 2010
Messages
833
Reason
PALS
Diagnosis
11/2010
Country
OS
State
Darkside of Moon
City
country
Thanks rknt, great information for all interested.
 

Ladyinn

Distinguished member
Joined
Apr 7, 2010
Messages
398
Reason
PALS
Diagnosis
11/2009
Country
US
State
South Dakota
City
Custer
I received a call from the clinic in Cleveland yesterday. After reviewing my medical records and the tests that my poor woman knowledge is in South Dakota has conducted, the conclusion of the staff in Cleveland is I do not qualify for the procedure. Having already been told that if he has not been done with a Medicare patient and I would have to put up $55,000 before they could do the procedure, I had pretty much made up my mind I was not going to have it done. Today, saved me from making a decision, it was made for me.

My FVC is 35% which immediately is dis-qualifying me. The girls told me that they have done the procedure in a test mode at this level and only one of the patients live longer than 48 hours. She lived a year. Not such great odds for me.

It sounds like a wonderful option for those who will qualify especially if they can get Medicare or their insurance company to pay. I'm not so sure it is a good option if you have to pay $55,000 upfront and wait to be reimbursed when Medicare finally agrees. We all know how fast government agencies accept change.
 

brooksea

Legendary member
Joined
Sep 27, 2006
Messages
5,226
Reason
Other
Country
HM
Diane, sorry about the DPS. Seems pALS wait too long at the table and have to leave, as the service is so slow and the price is too high.
 

MuonOne

Active member
Joined
Mar 8, 2010
Messages
79
Country
US
State
New York
City
New York
LadyInn:
" . . . that my poor woman knowledge is in South Dakota has conducted . . . "
I don't understand the aforementioned part of your message.
 
Status
Not open for further replies.
Top