Quote:
Originally Posted by JJames
(del.text) after so many years in pain, so many different tests and treatments, medications, procedures, and the opinions of 5+ surgeons
My question is, that after waiting for over a year (based upon when I believe the procedure was submitted to the U.S. FDA) for the procedure to be approved in the U.S. there does not appear to be any way to get the status of where this stands! I have not even been able to confirm it was ever submitted to the FDA! I've gone to the www.fda.gov website, and that is so confusing it is useless to me. I don't know where to look or who to ask. |
Five (5) surgeons, understand.
Four (4) surgeons on this side;
differing recommendations.
The two-level lumbar results may not be totally compiled or published. I suggest from my recall of professional journal abstracts (Spine, ISSLS, The Spine Journal, European Spine Journal) is there may be FDA controlled testing of two-level lumbar ADR, TDR, TDA, IVD ...
Clinical Trials
website, as an example see
Prodisc two-level is public information; this link may expire as it is a search link. Clinical Trials Identifier is
NCT00295009 , but his leads you back to the Prodisc single-level.
FDA
I am a layperson, not a governmental law expert, not a medical professionial, ... FDA Center for Device and Radiological Health (
CDRH www.fda.gov/cdrh ) is responsible for Artificial Disc Replacements . ADR is subject to Pre-Market Approval (
PMA).
FDA CDRH PMA Frequently Asked Question (
FAQs,
link) :
How can I find more information about a PMA under review?
Before FDA approves or disapproves a PMA, FDA will not disclose the existence of the PMA unless it previously has been publicly disclosed or acknowledged. Even if the existence of the PMA has been publicly disclosed or acknowledged, data or information contained in the file are not available for public disclosure. However, FDA may disclose a summary of portions of the safety and effectiveness data, if disclosure is relevant to public consideration of a specific pending issue.
There is other language I read on CDRH on information disclosure that provides a blanket or shield on disclosure. I read the policy, but can not find it now.
The FDA is not required to disclose preliminary ( two-level ADR ) results. FDA CDRH is not a patient's best source of clinical data before approval.
One example of this might be the Aesculap Activ-L lumbar Artificial Disc Replacement. There was a press release from the German company's American subsidiary that the FDA Clinical Trial started, or about to start, and nothing showed up in searches of FDA, FDA/CDRH or ClinicialTrials.Gov.