Diaphragm Pacing System
- Thread starter Buddha Nature
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Al
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To: Al Pettit
Date: June 4, 2010
Avery Biomedical Devices is pleased to announce that we have recently completed the transfer of our CE Marking Privileges for the Mark IV Breathing Pacemaker System
The EC Declaration of Conformity is based on an approved ISO-13485 quality system and a design examination by the Notified Body BSi Management Systems (London, UK). Should you require copies of these certifications for your files, please download them from our website at:
Regulatory Approvals | Avery Biomedical Devices, Inc.
Our European Manager and EC Representative is Dilys M. Gore, PhD. She can be reached at +44 1873 881168 or [email protected]. If you have any questions or concerns regarding this announcement, or would like to discuss an existing or prospective patient for a breathing pacemaker, please feel free to contact Dilys or me at your convenience.
Sincerely,
cid:[email protected]
Kenneth R. Aron
Vice President, Sales & Marketing
61 Mall Drive
Commack, NY 11725-5703 USA
Phone: 631-864-1600 x205, Fax: 631-864-1610
[email protected]
This email may contain material that is confidential and privileged. It is for the sole use of the intended recipient. If you are not the intended recipient, please contact the sender and delete all copies. Receipt by anyone other than the intended recipient is not a waiver of any physician-patient, attorney-client or other privilege.
Date: June 4, 2010
Avery Biomedical Devices is pleased to announce that we have recently completed the transfer of our CE Marking Privileges for the Mark IV Breathing Pacemaker System
The EC Declaration of Conformity is based on an approved ISO-13485 quality system and a design examination by the Notified Body BSi Management Systems (London, UK). Should you require copies of these certifications for your files, please download them from our website at:
Regulatory Approvals | Avery Biomedical Devices, Inc.
Our European Manager and EC Representative is Dilys M. Gore, PhD. She can be reached at +44 1873 881168 or [email protected]. If you have any questions or concerns regarding this announcement, or would like to discuss an existing or prospective patient for a breathing pacemaker, please feel free to contact Dilys or me at your convenience.
Sincerely,
cid:[email protected]
Kenneth R. Aron
Vice President, Sales & Marketing
61 Mall Drive
Commack, NY 11725-5703 USA
Phone: 631-864-1600 x205, Fax: 631-864-1610
[email protected]
This email may contain material that is confidential and privileged. It is for the sole use of the intended recipient. If you are not the intended recipient, please contact the sender and delete all copies. Receipt by anyone other than the intended recipient is not a waiver of any physician-patient, attorney-client or other privilege.
CRF8
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joel is correct in post above. Al may have some new info. I am unaware of. can you PM me for cost and Dr. contact? We did eventually recover most of the cost from our insurance but it took months and an attorney.
sadiemae
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We asked, and he thinks the VA in Palo Alto is doing it. He does not know much about it, but it is our main question to get an answer on tomorrow from the Neuro . Les had a FVC at 51% 3 months ago, yesterday it was 68%. HUGS Lori
Miss
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That's wonderful! Better is always good! It does make me question the test. l was told that it can always measure too low, never too high.
sadiemae
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OK, Jeff and Missy, and any other Vets out there. Some VA hospitals are doing this. We got a referral today to go to the VA in San Francisco for a consult on the pacer. The neuro sent a request to them while we were in her office, and requested a response time of one week. When we went in to see her today, I had a written list of 6 things we wanted accomplished. I started the visit with this list, she acted on each one, then she examined my husband. This was our third visit with her, so she is used to me and my lists, and lets me have my say. It is important to be in charge of your visits, ask questions and get results. We love her! By the way, we got everything we wanted! HUGS Lori
sadiemae
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YouTube- Diaphragm Pacing | Part 9 of 10 | Results in ALS Patients
Here is an excellent video on the Pacer. However it is not yet approved by the FDA.
Here is an excellent video on the Pacer. However it is not yet approved by the FDA.
Last edited by a moderator:
We just had the diaphragm pacing unit implanted last week and my friend is doing great. Before the surgery, one of his doctors suggested he be placed on bipap....after the surgery, we were informed he would not need bipap. His doctor feels with the use of the implant, he will be able to strengthen his muscles. His oxygen saturation was an 89 and now is 97. His voice is also stronger.
toby1414
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hope12, was your friend that received the diaphragm pacer by chance a Veteran? I am trying to get the VA to approve a pacer for my husband and am seeking other Vets that have one. Getting VA approval is tedious and any advice I can find would help!
Natural
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I did a short investigation into DPS here at Cleveland's University Hospital were it was pioneered. They have an open study going for those who qualify the cost is waived. You must pass the physical exam which among other things entails them verifying the nerve for your diaphragm will properly function. The other requirement was that you could not have an existing PEG tube which ruled me out. I was then referred to the Atlanta doctor and prepped me for a $50k cost. I elected not to pursue it any further at that point but it does sound like a good way to go for the right people. If you think that you might qualify, I believe the initial tests are all covered by insurance. You can then make a decision on what to do once you are qualified. Hope that helps.
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