According to results presented at TCT yesterday, the BIOSOLVE II study, met is primary angiographic endpoint. Furthermore, the results also showed that there was no evidence of scaffold thrombosis with the Biotronik’s magnesium scaffold. The data have been simultaneously published in The Lancet.
The aim of the BIOSOLVE II study was to investigate the safety and efficacy of a magnesium-based bioresorbable scaffold. The scaffold is designed to be completely absorbed within 12 months of implantation, which is faster than the absorption rate of polymer-based bioresorbable scaffolds.
In the first-in-man study, 123 patients were enrolled in Germany, Belgium, Denmark, the Netherlands, Switzerland, Spain, Brazil and Singapore. The trial’s primary endpoint was in-segment late lumen loss at six months: a late lumen loss of 0.27 ± 0.37mm was associated with the device. Additionally, a low rate of target lesion failure (3.3%) and a very low rate of myocardial infarction (0.8%) were observed. According to Biotronik, the results of the study will be used to obtain CE mark approval for the device.
Michael Haude (Lukaskrankenhaus, Neuss, Germany), who presented the data at TCT and who is the principal investigator of the study, says: “The results of BIOSOLVE-II confirm that the Biotronik magnesium scaffold is both a safe and effective option for treating coronary artery disease, and establish it as the first clinically-proven magnesium-based bioresorbable scaffold. The device’s favourable safety profile, as demonstrated by the lack of any scaffold thrombosis at six months from implantation, was especially remarkable.”
He added that the scaffold has advantages over synthetic polymer-based scaffolds because it can be inflated in a single step, noting “It is based on a natural element widely present in the human body, and the magnesium-based properties promote a faster and simpler implantation procedure.”