Learning more about the shunt & hydrocephalus

HAVE YOU EVER WANTED TO MEET A SHUNT “COMPANY” REPRESETNATIVE/SPECIALIST? HERE ARE SOME HIGHLIGHTS FROM OUR MEETING:

The meeting yesterday with the shunt/medical device representative could not have gone better.  The representative or “Nuero specialist” provided me with some great insight.  Additionally he offered to help in any reasonable way possible.  Some key points from the meeting included: 

What we call shunt failures are typically the proximal catheter (Catheter from the shunt to the ventricle) acquiring a buildup of protein and blocking CSF (Spinal fluid) flow from the ventricle to the shunt.  This particular representative expressed how from his perspective it’s viewed as a condition or by-product of hydrocephalus, not necessarily a “failure of the product”.  But stated that we need to have innovation that would prevent the buildup  and stop the blockage. 

This representative named Frank showed serious passion for innovation and the patient (It was nice to see excitement from a shunt representative).  He expressed the desire to improve the shunt technology to treat this condition.  We had shared thoughts on what shunts “Should” be able to do such as communicate wirelessly.  I expressed my frustration with the lack of innovation, for example we should be able to walk in to a doctor’s office and the doctor should be able to scan the shunt and download immediate data such as:  ICP (Intracranial Pressure) or for you new to hydrocephalus the pressure in your skull.  Downloadable data should include the CSF (Spinal Fluid) rate of flow, amount of CSF passing through the shunt, maybe the density of the CSF? (If density would give us any insight on the buildup of protein passing through the shunt?).

I learned a lot in a short amount of time.  I did not realize the shunt released by Codman (owned by Johnson & Johnson) was the only “New” shunt to hit the market in America in over 10 years!  Yes, 10 years (makes me nauseas to think of the lack of improvement).  This new shunt was on the European market years ago. . . .This brings me to our next challenge.  The FDA approval process is costly and a major bottleneck.  The process for implantable small medical devices is called 410K (I am still learning the 410K process).  I started learning about this process in January via the FDA you tube channel, listening to the process while driving home and to work and reading research document (referencing the dictionary several times).  The FDA claims the 410K  is a “Streamlined” process.  Nothing sounds streamlined about it.  The shunt representative would like to see innovation and I believe it’s not “all about the money” for him personally. We all want innovation! Innovation in how we treat hydrocephalus AND how new treatments and products are brought to the market while keeping safety the #1 priority.

This nuero specialist spends a lot of time in the operating room with the doctors during the surgical process.  If you live in the southeastern area of Michigan he may have been in the room watching the surgery you or your child was undergoing.  The leading cause of failures are due to the blockage in the catheter (from shunt to ventricle).  He says it almost looks like a build up of “Seaweed” at the end and when in the CSF within the ventricle cavity.

How do we design a catheter that is safe for implantation, infused with the anti-bacterial / anti-virus properties AND a new yet to be determined anti-protein infusion?  Let the brainstorming and dreaming begin!

Ultimately it goes without saying a medical procedure to CURE the life-threatening condition of hydrocephalus is the ultimate goal.  The second best option is improved technology and treatment.  Any questions or concerns or just want to chat about hydrocephalus e-mail me at Jason@hydrocephaluskids.org

 Signing off until next post,

Jason

Advocate for my son, one fighting hydrocephalus

Co-Director State of Michigan

PHF (Pediatric Hydrocephalus Foundation)