New Partnership Will Benefit the Speed Medical Devices Get to Market
Posted by amandagarzon on December 5, 2012 · 2 Comments
The first public-private partnership, called the Medical Device Innovation Consortium (MDIC), will prioritize the needs of the medical device community and fund projects to help simplify the process for medical devices to reach market. The FDA will be a part of the consortium that could potentially assist new developments in shunt technology.
Click here to read the press release.
I am amazed ar the number of neurologist who do not know much, if anything, about this disease.
When my husvand received a preliminary diagnoses of NPH at UC Davis in
June of this year there was a discussion of whether he should have a
shunt. The surgeon who was going to do the operation gave me a copy of a
Medline article that said a drain is not a determining factor in deciding
whether to do a shunt or not. I went on the WEB and there are many
articles just from Medline that support that conclusion. A few of them
are attached. See also the white paper
http://jnnp.bmj.com/content/72/4/503.full in the Journal of Neurology,
Neurosurgery and Psychiatry.
• e value of temporary external lumbar CSF drainage in predicting the
outcome of shunting on normal pressure hydrocephalus
• “The costs and invasiveness of the test and the possibility of serious
test related complications further limits its usefulness in managing
patients with presumed NPH.”
Thank you for taking the time to comment and share your opinions. Deciding on diagnosis and treatment of NPH is a very complex issue and individual to each person living with hydrocephalus. After reading your comments, we were intrigued by your situation and the information you referenced and so we conferred with one of the physicians on our Medical Advisory Board. The JNNP article that you reference is a good article, though 10 years old. However, the JNNP article does not imply that there is no value to CSF drainage; in fact, it states specifically that the positive predictive value of CSF drainage is high. It is rare that any single reference or publication is the one and only definitive paper on a topic so we wanted to share some other guidelines that are out there just to help further build the education of all of us in our community. The international hydrocephalus guidelines, published in 2005 show the range of tests available and their value in the diagnosis of NPH. There is international variation in the tests used. The Europeans tend to use infusion testing (outflow resistance) or the tap test. The Japanese like MRI and the tap test, and their guidelines were recently updated. Many of the U.S. centers use either extended CSF drainage or tap test. The real issue is that NPH is hard to diagnose, and it does require evaluation of the physiology…not just the history, the neurologic examination, and the scans. Evaluation of physiology means either infusion testing, tap test, or extended CSF drainage. Most of the time, this means that patients should be referred to centers of expertise. Further, according to the member of our Medical Advisory Board, it is rare for patients to have only NPH. They often have multiple disorders that contribute to their symptoms, and the challenge is to identify whether the contribution of NPH to their symptoms, if any, is sufficient to warrant shunt surgery. We hope this helps provide some insight into the thought process on the part of the neurologist and neurosurgeon when discussing your husband’s treatment options. Also, we hope in the end all of you as a team were able to make the best decision possible for your husband. Of course, if you have further questions that we can help answer, please do not hesitate to contact us directly or through our website.