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. Link here. 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. "
What that means related to time is
that before a new clinic can go forward with any surgery they need to have a full
review by an individual clinics' IRB. The average time for a study to be approved is 90
days. That is 90 days from when the application is finalized and
submitted to have it reviewed, revised, and presented to several
committees, etc. As this study is related to a surgical procedure they
anticipate it may be a more involved review and take longer than 90
days. Add these 90-180 days in as the earliest probability of any new clinic to be up and running and we are looking practically at Spring 2012 for the initial roll out and probably end of 2012 for reasonably strong geographic coverage. (On a side note I am unclear as to the timing of the half dozen or so clinics that previously were involved in the clinical trials. In theory, their approval times should be quicker but I have been unable to confirm).
Tough call as a patient that is progressing as to whether to wait to do this locally or travel. Plan on 5 days in Cleveland as an outpatient. Travel by air or car, hotel rooms, food, local transportation if you fly, etc. Add in a caregiver for some. Total cost for me (not counting the surgery) coming from LA with a caregiver would be around $5,000. Then if there are complications or follow up the costs and inconvenience get even larger. Leaning heavily on waiting to do this locally and crossing my fingers on timing and qualification, but may not have that option.
Medically there are a few things they test to see if you can benefit. Goal is to keep the patient breathing with his or her own muscles for as long as possible. Augie Nieto went on this device shortly after diagnosis and made it six years before getting a trache. The tests run to evaluate whether the diaphragm is stimulatable are a Fluoroscopy of the diaphragm (simple scan) and a Phrenic Nerve Conduction Test (not for the faint of heart). It is important to determine if the diaphragm is stimulatable prior to beginning the procedure. The PCNT shows diaphragm movement and positive response. For Diaphragm Pacing to help, the diaphragm must respond to the electronic stimulation.
Insurance-wise, I was told even prior to FDA approval, the hospital has performed many these procedures on ALS patients that were approved by Medicare/ Private Insurance. At least 50% were covered. Now that it is FDA approved, they anticipate the coverage success rate should grow significantly. Link here.
I spoke to the caregiver of an ALS patient that participated in the clinical trial at Stanford University and she highly recommends the procedure. Felt good to confirm my thoughts on this by speaking with an actual patient. Highly recommend anyone considering this procedure (or any other of significance for that matter) to do the same. There are HIPPA laws that prevent the clinics, MDA or ALSA from giving you patient information directly. But they can call the patient or caregiver on your behalf and ask if they would be willing to speak with you and answer some questions. Almost never has a patient turned me down and I am always willing to return the favor when asked as well.
I aggressively approached the lead ALS Neurologists at both ALSA certified Cedars Sinai and MDA certified UC Irvine. Ask both of them to look into it and they agreed. If you are interested in having your local clinic participate, suggest you do the same. Make sure to include the potential surgical team leader at the clinic as well. Tell them the contact person at Synapse Biomedical is Steve Annunziato. He can be reached at (440) 774-2488 or sannunziato@synapsebiomedical.com.
University Hospitals in Cleveland contacts:
MaryJo Elmo
Nurse Practitioner
Case Western Reserve University
University Hospitals of Cleveland
Cleveland, OH
United States
Phone: (216) 844-8594
maryjo.elmo@uhhs.com
Raymond P Onders MD
Director of Minimally Invasive Surgery
Case Western Reserve University
University Hospitals of Cleveland
11100 Euclid Avenue
Cleveland, OH 44106
United States
Phone: (216) 844-5797
raymond.onders@uhhs.com
You Tube Video (10 parts) with Dr. Onders presenting his findings from November, 2009.
My intent is not to criticize this procedure in any way, nor to
criticize the "system." I'll leave that to the many others that undoubtedly will weigh in with their negative or positive opinion, as they should. It's simply to provide neutral, important and
practical information from a patients point or view. Like all data or
information, it's up to you how to use it or not use it. It's your body, your life, and it's
completely up to you.
Just One Man's Opinion.
