RMB. thx for that link ....re ICU Survival was even higher if the kids weren't on ECMO ...something like 97% ! So they were CRRT ( dialysis ) and Cardio assist meds but hadn't declined as far as needing ECMO ( ventilators ) . Because this was a special Pediatric trial they didn't run P values because the clinical benefit was so dramatic ...but its assumed to be at least P<.01 .
The registry that was set up is indicating even better results than the trial ...maybe by starting the SCD device earlier ....or just fewer kids needing ECMO .
Kidney wk ...Nov 2025 is going to be big for this Co . They'll have the Adult interim review opinion and more data from the Pediatric registry .
The key to track for the sleuths here ...is updates on enrollment in the Adult trial
Here's a link to a much earlier article going back to March 2021. It references the P values under "Analyses" and states..."As noted above, this US FDA funded and approved study was conducted to evaluate the safety of the SCD in children weighing more than 15 kg to support application for a Humanitarian Device Exemption. Given the small agreed upon sample size, no claims of efficacy could be made owing to a lack of power."
It's sad to think this technology has been waiting in the wings for approval as long as it has.
No scientist am I. That's why I defer to Kiwi for interpreting these hieroglyphics!
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