Transcript Below :
Question 1 : How does the design of a RMS compare to a bioresorbable vascular scaffold?
The metallic magnesium scaffold is completely different from the PLA scaffold due to the alloy, first of all, but probably the other important characteristic is the complete reabsorption at 12 months. The scaffolding time of three, four months and a complete [Inaudiable] at one month with a low thrombogenicity due to the magnesium properties, and also the reabsorption, is unique in this particular category of scaffold.
Question 2 : What data supports use of RMS to date?
The data regarding MRS magnesium is related to BIOSOLVE study. Especially the BIOSOLVE-IV, large, worldwide registry show the result in selected population, where today we only two size of scaffold available and the select population is very important. But the results at one year are promising and similar to the DS of second generation.
Question 3 : With stent thrombosis concerns, what is the safety data on RMS devices?
Scaffold thrombosis, if it is a big problem for the PLLA scaffold, seem not a problem for a magnesium. For one reason, due to the characteristic of the low thrombogenicity of the magnesium. And in the clinical trial, the number of the cases of the thrombosis is very, very low. In the large registry is zero, less than 0.5, and is very important. Probably the particular characteristic of the magnesium reduce these adverse events.
Question 4 : How can operators maximise outcomes with RMS? Is PSP needed?
Absolutely yes. The rule to implantation is the name of four P's. It's similar to the PSP, and we have the four P. The first P is the patient selection, is very important. And also predilation, proper [Inaudible], post-dilatation. We believe that the biosolvable scaffolding in this case magnesium, the lesion preparation is crucial like in the PSP registry. And I believe, that is different from the DS. If you want to use the biosolvable scaffold you respect, very well, the four P rules.
Question 5 : Is there still a future for the RMS in clinical practice considering newer generation DES outcomes?
I believe that, at the moment, with the sizing available, the magnesium scaffold in the clinical practice is useful in very selected populations, probably 50% of the population. But now we're arrived the new version with more size, more length and different design, and I hope that to open another scenario, but at this moment for honest, it's possible to compare this device with DES of second generation, in selected populations. Not in all cases.