FDA Petition on Anti Siphon CNS Shunts
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stephen-dolle -
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This is the ever so critical petition I authored on CNS anti siphon shunts, used in the treatment of hydrocephalus, and filled with the Food and Drug Administration. Out of this, I conceived and patented the DiaCeph Test for shunt malfunction and shunt outcomes, which could be an app for mobile phones today. I also am a CNS shunt user and undertook these efforts initially out of my mere survival. This 1996 petition then triggered the 1999 STAMP Conference in Washington D.C.. But, I was not asked to speak and represent the patient community on the STAMP panel I suspect since my petition criticized a Medtronic company device. Medtronic since integrated this anti siphon tecnnology into its programmable Strata shunts, and again misled the field as to its safe and efficacious use. As of 2011, I've undergone 9 shunt revisions and have observed actionable failures in 6 of these.