DyeVert Power XT - Has real efficacy? Different to Plus and Plus EX?

So is the DyeVert Power XT (which just got CE make) a different product to the DyeVert Plus and DyeVert Plus EZ systems?

The previous DyeVert systems (Plus and Ples EZ) didn't have a great indication for use from the FDA (only that it reduced dye, not that it reduced Acute Kidney Injury (AKI)). The results of the study for the new system (Power XT) appears to have had a substantial reduction in AKI, which would give you a real efficacy result (which wasn't shown in the US study).

I think the efficacy result (which should be able to be also carried over to the US) is a much bigger announcement than the CE mark... Or am I missing something? Or is the company just awful at communicating?

Study Design
- Patients studied hadheart attacks(STEMI and NSTEMI)
- 339 control patients(no-DyeVert) were compared to 112 patients who received DyeVert
- Hydration(IV fluid administration)protocol was the same in both DyeVert and no-DyeVert
- Observed, retrospective, propensity matched study in a single center in Naples Italy

Results
- 38% dye reduction in the DyeVert group compared to the no-DyeVert group
- 58% Acute Kidney Injury reduction in the DyeVert group compared to the no-DyeVert group
- 25% reduction in hospital length of stay in the DyeVert group compared to the no-DyeVert group

A link to the abstract is available at https://pubmed.ncbi.nlm.nih.gov/32682348/.

Results from the abstract:
Results: CM volume was higher in the Control group than in the DyeVert group (130 [120-188] ml vs. 99 [69-136] ml; p <.001). In the DyeVert group the mean percent CM volume saved was 38 ± 13%. AKI occurred in 7/90 patients (8%) in the DyeVert group and in 17/90 (19%) patients in the Control group (odds ratio = 0.37; 95% confidence interval 0.14-0.95; p =.047).