So we recently learned about the new port-a-cath that is contemplated to be used in the next phases of the intrathecal clinical trial. If you’ve followed along, you’ll know that the current port has suffered from a number of problems, mostly due to the high activity level of our kids. The current port was already approved in the EU, but if I understand correctly, it was used mostly with CP and/or wheelchair bound or low-activity patients.
Well, it was tested in monkeys before our trial and I always joke that “Don’t you know that our Hunter boys are much more active than monkeys? They might not swing from the trees, but they jump from the furniture, wrestle with their brothers, and crash into just about anything!”
So, a more sturdy port was in order. Enter Sophysa’s soph-a-port mini.
Now, although I understand that Shire has an agreement with this company, my understanding is that it is not currently approved by the FDA for use in the United States and it still must go through that process, which may take until the end of the year, if I understand correctly. Notice my caveats…. 😉
However, I am happy to say that I am encouraged by the new port. The design seems sturdy for our kids and I’m hopeful that it can withstand their high activity level and I don’t have to constantly be concerned about a broken port each month, especially with a treatment that would likely have to happen each month for the rest of his life (which will hopefully be long as a result!).
With the new port also comes a new catheter (the “tube” that carries the drug from the device around the side, into the spinal fluid). The current catheter also suffered from some durability issues, as I understand, and keeping it in the spinal canal was sometimes a challenge. I am told that the issue of them sliding out is is a not uncommon side effect of spinal catheters, however. This may be addressed by a kind of butterfly clip at the base of the spine to keep the catheter from sliding out.
In the end, I still have some questions that need answering, so I would love to crowdsource additional questions if you have them, so post below:
Thank you for any additional thoughts you provide!